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.

Recruitment status

COMPLETED

Target enrollment

94 participants

Primary outcome timeframe

2-hour period

Results posted on

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

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.
Overall Study
STARTED
48
46
Overall Study
COMPLETED
44
46
Overall Study
NOT COMPLETED
4
0

Reasons for withdrawal

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

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.
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 period

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.

Outcome measures

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 period

Mother 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Breastfeeding Condition - Infants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Bottle-feeding Condition - Mothers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Bottle-feeding Condition - Infants

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

Dr. Alison Ventura

California Polytechnic State University

Phone: (805) 756-5693

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place