Trial Outcomes & Findings for Breast Versus Bottle Study (NCT NCT03704051)
NCT ID: NCT03704051
Last Updated: 2024-02-28
Results Overview
For both breast- and bottle-feedings, infant intake will be assessed by pre- and post-weighing the baby on an infant scale (model 374; Seca, Hamburg, Germany). During bottle-feedings, we will also note whether the infant finishes the bottle.
COMPLETED
94 participants
2-hour period
2024-02-28
Participant Flow
Mothers of infants under 6 months of age were recruited through advertisements on social media platforms (e.g. Facebook and Instagram); advertisements in local Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) clinics; announcements in birthing, breastfeeding and parenting classes; and flyers displayed at local businesses.
There were no significant events in the study (for example, wash out, run-in) that occurred after participant enrollment, but prior to the first within-subject condition.
Participant milestones
| Measure |
Breastfeeding First, Then Bottle-feeding
Mother-infant dyads in this group breastfed during the first visit, then bottle-fed expressed breast milk during the second visit.
|
Bottle-Feeding First, Then Breastfeeding
Mother-infant dyads in this group bottle-fed expressed breast milk during the first visit, then breast-fed during the second visit.
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|---|---|---|
|
Overall Study
STARTED
|
48
|
46
|
|
Overall Study
COMPLETED
|
44
|
46
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Breastfeeding First, Then Bottle-feeding
Mother-infant dyads in this group breastfed during the first visit, then bottle-fed expressed breast milk during the second visit.
|
Bottle-Feeding First, Then Breastfeeding
Mother-infant dyads in this group bottle-fed expressed breast milk during the first visit, then breast-fed during the second visit.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
Baseline Characteristics
Data are for mothers only (n = 47)
Baseline characteristics by cohort
| Measure |
All Study Participants
n=94 Participants
This was a within-subject study; all mother-infant dyads (47 mothers + 47 infants = 94 participants total) were exposed to both conditions and the order of presentation was counterbalanced across dyads. Because all dyads were randomized to receive all interventions, all will be combined into one arm/group for the summary that follows.
Mode of Feeding (breastfeeding versus bottle-feeding): Infants will be breastfed during one lab visit and bottle-fed (with expressed breast milk) during the other.
|
|---|---|
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Age, Continuous
|
3.2 months
STANDARD_DEVIATION 1.4 • n=47 Participants • Data are for infants only (n = 47)
|
|
Sex: Female, Male
Female
|
20 Participants
n=47 Participants • Data are for infants only (n = 47)
|
|
Sex: Female, Male
Male
|
27 Participants
n=47 Participants • Data are for infants only (n = 47)
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=94 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=94 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=94 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=94 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=94 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=94 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=94 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=94 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=94 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=94 Participants
|
|
Region of Enrollment
United States
|
94 participants
n=94 Participants
|
PRIMARY outcome
Timeframe: 2-hour periodFor both breast- and bottle-feedings, infant intake will be assessed by pre- and post-weighing the baby on an infant scale (model 374; Seca, Hamburg, Germany). During bottle-feedings, we will also note whether the infant finishes the bottle.
Outcome measures
| Measure |
Breast- Versus Bottle-feeding
n=47 dyads
This was a within-subject study; all mother-infant dyads were exposed to both conditions: breastfeeding versus bottle-feeding with expressed breast milk
Order of presentation was counterbalanced.
|
|---|---|
|
Infant Intake During the Observed Feeding (mL)
Breastfeeding Condition
|
91.9 mL
Standard Error 5.0
|
|
Infant Intake During the Observed Feeding (mL)
Bottle-feeding Condition
|
87.6 mL
Standard Error 5.2
|
PRIMARY outcome
Timeframe: 2-hour periodMother and infant behavior during each feeding will be coded using the Nursing Child Assessment Parent-Child Interaction - Feeding Scale (NCAFS). This scale contains six subscales, four of which describe maternal attributes (Sensitivity to Cues, Response to Child's Distress, Social-Emotional Growth Fostering, and Cognitive Growth Fostering) and two of which describe infant attributes (Clarity of Cues and Responsiveness to Caregiver). The proposed analysis will focus on the Sensitivity to Cues subscale, which measures the degree to which the mother is able to understand and respond to her child's cues. This scale provides a global measure of how sensitive the mother is to the infant's needs during the feeding interaction. Possible score range is 0-16, which is derived from summing together maternal scores for each of the 16 subscale items. Higher scores indicate greater sensitivity to infant cues.
Outcome measures
| Measure |
Breast- Versus Bottle-feeding
n=47 dyads
This was a within-subject study; all mother-infant dyads were exposed to both conditions: breastfeeding versus bottle-feeding with expressed breast milk
Order of presentation was counterbalanced.
|
|---|---|
|
Maternal Sensitivity to Infant Cues
Breastfeeding Condition
|
14.7 units on a scale
Standard Error 0.2
|
|
Maternal Sensitivity to Infant Cues
Bottle-feeding Condition
|
14.3 units on a scale
Standard Error 0.2
|
Adverse Events
Breastfeeding Condition - Mothers
Breastfeeding Condition - Infants
Bottle-feeding Condition - Mothers
Bottle-feeding Condition - Infants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Alison Ventura
California Polytechnic State University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place