Trial Outcomes & Findings for Social Media and Risk Reduction Teaching-Enhanced Reach (NCT NCT04387552)
NCT ID: NCT04387552
Last Updated: 2026-08-26
Results Overview
An investigator-developed maternal survey will be used to assess infant's sleep position during the previous two weeks with categorical responses of supine (back), prone (stomach), side, and other.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2093 participants
Primary outcome timeframe
Between 2 and 6 months following postnatal randomization, on average 67.7 days
Results posted on
2026-08-26
Participant Flow
303 of the 2093 enrolled were not randomized prenatally due to: participant choice (165), study ended (56), pregnancy loss (26), delivery \<34 wks (17), contraindications (17), not pregnant (15), other (7). Infants were not considered to be enrolled.
There was a 2- step randomization process- prenatally to 2 arms (n=1790, 897 randomized to prenatal safe sleep/SS and 893 randomized to prenatal breastfeeding/BF) and postnatally to 4 arms (n=1775). 15 of the 1790 randomized prenatally were not randomized postnatally- 7 of the 897 randomized to safe sleep/SS due to: participant choice (6), pregnancy loss (1), and 8 of the 893 randomized to breastfeeding/BF due to: participant choice (6), changed contact (1), pregnancy loss (1).
Participant milestones
| Measure |
Prenatal SS/Postnatal SS
Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal SS/Postnatal BF
Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
Prenatal BF/Postnatal SS
Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal BF/Postnatal BF
Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
Safe Sleep/SS
Participants randomized to this arm received safe sleep messaging in the prenatal period.
|
Breastfeeding/BF
Participants randomized to this arm received infant feeding messaging in the prenatal period.
|
|---|---|---|---|---|---|---|
|
Prenatal Randomization Into 2 Arms
STARTED
|
0
|
0
|
0
|
0
|
897
|
893
|
|
Prenatal Randomization Into 2 Arms
COMPLETED
|
0
|
0
|
0
|
0
|
890
|
885
|
|
Prenatal Randomization Into 2 Arms
NOT COMPLETED
|
0
|
0
|
0
|
0
|
7
|
8
|
|
Postnatal Randomization Into 4 Arms
STARTED
|
440
|
450
|
438
|
447
|
0
|
0
|
|
Postnatal Randomization Into 4 Arms
COMPLETED
|
346
|
350
|
338
|
349
|
0
|
0
|
|
Postnatal Randomization Into 4 Arms
NOT COMPLETED
|
94
|
100
|
100
|
98
|
0
|
0
|
Reasons for withdrawal
| Measure |
Prenatal SS/Postnatal SS
Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal SS/Postnatal BF
Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
Prenatal BF/Postnatal SS
Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal BF/Postnatal BF
Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
Safe Sleep/SS
Participants randomized to this arm received safe sleep messaging in the prenatal period.
|
Breastfeeding/BF
Participants randomized to this arm received infant feeding messaging in the prenatal period.
|
|---|---|---|---|---|---|---|
|
Prenatal Randomization Into 2 Arms
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Prenatal Randomization Into 2 Arms
pregnancy loss
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Prenatal Randomization Into 2 Arms
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Postnatal Randomization Into 4 Arms
Lost to Follow-up
|
89
|
91
|
91
|
89
|
0
|
0
|
|
Postnatal Randomization Into 4 Arms
Discontinued intervention
|
5
|
9
|
9
|
9
|
0
|
0
|
Baseline Characteristics
Social Media and Risk Reduction Teaching-Enhanced Reach
Baseline characteristics by cohort
| Measure |
Prenatal SS/Postnatal SS
n=346 Participants
Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal SS/Postnatal BF
n=350 Participants
Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
Prenatal BF/Postnatal SS
n=338 Participants
Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal BF/Postnatal BF
n=349 Participants
Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
Total
n=1383 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<24 years
|
69 Participants
n=31 Participants
|
77 Participants
n=49 Participants
|
72 Participants
n=80 Participants
|
66 Participants
n=29 Participants
|
284 Participants
n=106 Participants
|
|
Age, Customized
24-29 years
|
112 Participants
n=31 Participants
|
113 Participants
n=49 Participants
|
101 Participants
n=80 Participants
|
117 Participants
n=29 Participants
|
443 Participants
n=106 Participants
|
|
Age, Customized
30-34 years
|
94 Participants
n=31 Participants
|
98 Participants
n=49 Participants
|
97 Participants
n=80 Participants
|
86 Participants
n=29 Participants
|
375 Participants
n=106 Participants
|
|
Age, Customized
35+ years
|
71 Participants
n=31 Participants
|
62 Participants
n=49 Participants
|
68 Participants
n=80 Participants
|
80 Participants
n=29 Participants
|
281 Participants
n=106 Participants
|
|
Sex: Female, Male
Female
|
346 Participants
n=31 Participants
|
350 Participants
n=49 Participants
|
338 Participants
n=80 Participants
|
349 Participants
n=29 Participants
|
1383 Participants
n=106 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
|
Race/Ethnicity, Customized
Hispanic, any race
|
96 Participants
n=31 Participants
|
74 Participants
n=49 Participants
|
78 Participants
n=80 Participants
|
77 Participants
n=29 Participants
|
325 Participants
n=106 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, Black
|
83 Participants
n=31 Participants
|
76 Participants
n=49 Participants
|
78 Participants
n=80 Participants
|
86 Participants
n=29 Participants
|
323 Participants
n=106 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, Other
|
28 Participants
n=31 Participants
|
28 Participants
n=49 Participants
|
22 Participants
n=80 Participants
|
31 Participants
n=29 Participants
|
109 Participants
n=106 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, White
|
131 Participants
n=31 Participants
|
165 Participants
n=49 Participants
|
153 Participants
n=80 Participants
|
149 Participants
n=29 Participants
|
598 Participants
n=106 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
8 Participants
n=31 Participants
|
7 Participants
n=49 Participants
|
7 Participants
n=80 Participants
|
6 Participants
n=29 Participants
|
28 Participants
n=106 Participants
|
|
Region of Enrollment
United States
|
346 participants
n=31 Participants
|
350 participants
n=49 Participants
|
338 participants
n=80 Participants
|
349 participants
n=29 Participants
|
1383 participants
n=106 Participants
|
PRIMARY outcome
Timeframe: Between 2 and 6 months following postnatal randomization, on average 67.7 daysPopulation: The number of participants analyzed in each arm reflects the total number of participants that provided information about their infant's sleep position.
An investigator-developed maternal survey will be used to assess infant's sleep position during the previous two weeks with categorical responses of supine (back), prone (stomach), side, and other.
Outcome measures
| Measure |
Prenatal SS/Postnatal SS
n=337 Participants
Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal SS/Postnatal BF
n=344 Participants
Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
Prenatal BF/Postnatal SS
n=334 Participants
Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal BF/Postnatal BF
n=348 Participants
Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
|---|---|---|---|---|
|
Number of Infants Usually Sleeping Supine in the Previous Two Weeks
|
308 Participants
|
317 Participants
|
299 Participants
|
305 Participants
|
PRIMARY outcome
Timeframe: Between 2 and 6 months following postnatal randomization, on average 67.7 daysPopulation: The number of participants analyzed in each arm reflects the total number of participants that provided information about their infant's sleep location.
An investigator-developed maternal survey will be used to assess the infant's sleep location during the previous two weeks with categorical responses of room sharing without bed sharing, room sharing with bed sharing, no room sharing and no bed sharing.
Outcome measures
| Measure |
Prenatal SS/Postnatal SS
n=332 Participants
Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal SS/Postnatal BF
n=334 Participants
Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
Prenatal BF/Postnatal SS
n=327 Participants
Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal BF/Postnatal BF
n=334 Participants
Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
|---|---|---|---|---|
|
Number of Infants Usually Room Sharing Without Bedsharing in the Previous Two Weeks
|
297 Participants
|
292 Participants
|
287 Participants
|
280 Participants
|
PRIMARY outcome
Timeframe: Between 2 and 6 months following postnatal randomization, on average 67.7 daysPopulation: The number of participants analyzed in each arm reflects the total number of participants that provided information about soft bedding around their infant.
An investigator-developed maternal survey will be used to assess soft bedding placed in and around the infant (while sleeping) during the previous two weeks with categorical responses of Yes or No.
Outcome measures
| Measure |
Prenatal SS/Postnatal SS
n=336 Participants
Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal SS/Postnatal BF
n=344 Participants
Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
Prenatal BF/Postnatal SS
n=326 Participants
Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal BF/Postnatal BF
n=344 Participants
Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
|---|---|---|---|---|
|
Number of Infants With no Soft Bedding Use in the Previous Two Weeks
|
284 Participants
|
274 Participants
|
251 Participants
|
260 Participants
|
PRIMARY outcome
Timeframe: Between 2 and 6 months following postnatal randomization, on average 67.7 daysPopulation: The number of participants analyzed in each arm reflects the total number of participants that provided information about their pacifier use.
An investigator-developed maternal survey will be used to assess the infant's pacifier use during the previous two weeks with categorical responses of Yes or No.
Outcome measures
| Measure |
Prenatal SS/Postnatal SS
n=333 Participants
Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal SS/Postnatal BF
n=342 Participants
Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
Prenatal BF/Postnatal SS
n=331 Participants
Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal BF/Postnatal BF
n=339 Participants
Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
|---|---|---|---|---|
|
Number of Infants With Pacifier Use in the Previous Two Weeks
|
249 Participants
|
260 Participants
|
240 Participants
|
255 Participants
|
PRIMARY outcome
Timeframe: Between 2 and 6 months following postnatal randomization, on average 67.7 daysPopulation: The number of participants analyzed in each arm reflects the total number of participants that provided information about their infant's feeding.
An investigator-developed maternal survey will be used to assess whether the infant was breast fed during the previous two weeks with categorical responses of exclusively breast fed, partially breast fed, or not breast fed.
Outcome measures
| Measure |
Prenatal SS/Postnatal SS
n=340 Participants
Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal SS/Postnatal BF
n=347 Participants
Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
Prenatal BF/Postnatal SS
n=337 Participants
Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal BF/Postnatal BF
n=348 Participants
Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
|---|---|---|---|---|
|
Number of Infants With Any Breastmilk Feeding in the Previous Two Weeks
|
234 Participants
|
222 Participants
|
212 Participants
|
223 Participants
|
SECONDARY outcome
Timeframe: Between 2 and 6 months following postnatal randomization, on average 67.7 daysPopulation: The number of participants analyzed in each arm reflects the total number of participants that provided information about their infant's sleep position.
An investigator-developed maternal survey will be used to assess infant's sleep position during the previous two weeks
Outcome measures
| Measure |
Prenatal SS/Postnatal SS
n=337 Participants
Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal SS/Postnatal BF
n=343 Participants
Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
Prenatal BF/Postnatal SS
n=334 Participants
Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal BF/Postnatal BF
n=348 Participants
Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
|---|---|---|---|---|
|
Number of Infants Exclusively Sleeping Supine in the Previous Two Weeks
|
254 Participants
|
240 Participants
|
220 Participants
|
212 Participants
|
SECONDARY outcome
Timeframe: Between 2 and 6 months following postnatal randomization, on average 67.7 daysPopulation: The number of participants analyzed in each arm reflects the total number of participants that provided information about their infant's sleep location.
An investigator-developed maternal survey will be used to assess the infant's sleep location during the previous two weeks with categorical responses of room sharing without bed sharing, room sharing with bed sharing, no room sharing and no bed sharing.
Outcome measures
| Measure |
Prenatal SS/Postnatal SS
n=336 Participants
Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal SS/Postnatal BF
n=344 Participants
Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
Prenatal BF/Postnatal SS
n=324 Participants
Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal BF/Postnatal BF
n=338 Participants
Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
|---|---|---|---|---|
|
Number of Infants Exclusively Room Sharing Without Bedsharing in the Previous Two Weeks
|
243 Participants
|
240 Participants
|
232 Participants
|
219 Participants
|
SECONDARY outcome
Timeframe: Between 2 and 6 months following postnatal randomization, on average 67.7 daysPopulation: The number of participants analyzed in each arm reflects the total number of participants that provided information about their infant's feeding.
An investigator-developed maternal survey will be used to assess whether the infant was breast fed during the previous two weeks with categorical responses of exclusively breast fed, partially breast fed, or not breast fed.
Outcome measures
| Measure |
Prenatal SS/Postnatal SS
n=340 Participants
Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal SS/Postnatal BF
n=347 Participants
Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages
Prenatal Safe Sleep Mobile Health (mHealth) Messaging: Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
Prenatal BF/Postnatal SS
n=337 Participants
Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Safe Sleep Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
|
Prenatal BF/Postnatal BF
n=348 Participants
Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages
Prenatal Breastfeeding Mobile Health (mHealth) Messaging: Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
Postnatal Breastfeeding Mobile Health (mHealth) Messaging: Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
|
|---|---|---|---|---|
|
Number of Infants With Exclusive Breastmilk Feeding in the Previous Two Weeks
|
116 Participants
|
106 Participants
|
107 Participants
|
117 Participants
|
Adverse Events
Prenatal SS/Postnatal SS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prenatal SS/Postnatal BF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prenatal BF/Postnatal SS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prenatal BF/Postnatal BF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael J. Corwin, MD
Boston University School of Public Health & Pediatrics, Chobanian & Avedisian BUSM
Phone: (617) 734-6006
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place