Trial Outcomes & Findings for Feeding and Transition to Home for Preterms at Social Risk (NCT NCT02041923)
NCT ID: NCT02041923
Last Updated: 2021-04-13
Results Overview
Orally directed behavioral cues (hand to mouth, hand swipes at mouth, sucking on hand, sucking on tongue, tonguing) per week.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
198 participants
Primary outcome timeframe
From birth to 36 weeks
Results posted on
2021-04-13
Participant Flow
Infants and their mothers were screened by the research team. Mothers of eligible infants were approached for consent. We had IRB approval to recruit 230 mother-infants dyads. We recruited 198 total mother-infant dyads.
Random assignment was conducted after enrollment.
Participant milestones
| Measure |
Attention Control
Mothers received equal amount of attention from the team
H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants.
|
H-HOPE Intervention
H-HOPE was administered twice daily by the mother.
H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
96
|
|
Overall Study
COMPLETED
|
76
|
66
|
|
Overall Study
NOT COMPLETED
|
26
|
30
|
Reasons for withdrawal
| Measure |
Attention Control
Mothers received equal amount of attention from the team
H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants.
|
H-HOPE Intervention
H-HOPE was administered twice daily by the mother.
H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
26
|
30
|
Baseline Characteristics
Feeding and Transition to Home for Preterms at Social Risk
Baseline characteristics by cohort
| Measure |
Attention Control
n=102 Participants
Mothers received equal amount of attention from the team
H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants.
|
H-HOPE Intervention
n=96 Participants
H-HOPE was administered twice daily by the mother.
H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants.
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 weeks of gestation
STANDARD_DEVIATION 1.6 • n=99 Participants
|
32 weeks of gestation
STANDARD_DEVIATION 1.7 • n=107 Participants
|
32 weeks of gestation
STANDARD_DEVIATION 1.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
47 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · Black or African American
|
55 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · White
|
47 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
55 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
latino
|
47 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=99 Participants
|
96 participants
n=107 Participants
|
198 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From birth to 36 weeksOrally directed behavioral cues (hand to mouth, hand swipes at mouth, sucking on hand, sucking on tongue, tonguing) per week.
Outcome measures
| Measure |
Attention Control
n=102 Participants
Mothers received equal amount of attention from the team.
|
H-HOPE Intervention
n=96 Participants
H-HOPE was administered twice daily by the mother.
H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants.
|
|---|---|---|
|
Infant Behavioral Organization
|
33.2 Orally directed behavioral cues per week
Standard Deviation 42.4
|
51.8 Orally directed behavioral cues per week
Standard Deviation 56.7
|
PRIMARY outcome
Timeframe: 34 - 44 weeks postmenstrual ageMother-infant interaction during feeding measured via the Nursing Child Assessment Feeding Scale (NCAFS). The NCAFS possible scores ranged from 0-76. A higher score indicates a better outcome.
Outcome measures
| Measure |
Attention Control
n=76 Participants
Mothers received equal amount of attention from the team.
|
H-HOPE Intervention
n=66 Participants
H-HOPE was administered twice daily by the mother.
H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants.
|
|---|---|---|
|
Mother-Infant Interaction
|
62.5 units on a scale
Standard Deviation 7.0
|
64.3 units on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: from birth to hospital discharge, up to 9 weeksInfant growth in weight gain was measured at entry I into the study and at hospital discharge.
Outcome measures
| Measure |
Attention Control
n=37 Participants
Mothers received equal amount of attention from the team.
|
H-HOPE Intervention
n=36 Participants
H-HOPE was administered twice daily by the mother.
H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants.
|
|---|---|---|
|
Infant Growth
|
2038 weight in grams
Standard Deviation 228
|
2051 weight in grams
Standard Deviation 284
|
SECONDARY outcome
Timeframe: Illness visits within 6 weeks post hospital dischargePopulation: Infant outpatient illness appointments
Illness visits within 6 weeks post discharge
Outcome measures
| Measure |
Attention Control
n=69 Participants
Mothers received equal amount of attention from the team.
|
H-HOPE Intervention
n=78 Participants
H-HOPE was administered twice daily by the mother.
H-HOPE: Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants.
|
|---|---|---|
|
Health Care Utilization
|
15 Illness visits
Standard Deviation 2.8
|
10 Illness visits
Standard Deviation 1.2
|
Adverse Events
Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
H-HOPE Intervention
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place