Breast Versus Bottle Study

Completed

• Conditions: Bottle Feeding; Breastfeeding
• Interventions: Behavioral: Mode of Feeding (breastfeeding versus bottle-feeding)

• Registration Number: NCT03704051
• Lead Sponsor: California Polytechnic State University-San Luis Obispo

Brief Summary

The objective of the proposed research is to conduct a within-subject experimental study that will assess the effect of feeding mode (breast- versus bottle-feeding) on the quality and outcome of infant feeding interactions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-12
• Study Start: 2018-10-15
• Primary Completion: 2020-03-15
• Study Completion: 2021-07-01
• Results First Submitted: 2022-07-22
• Results First Submitted QC: 2022-10-21
• Results First Posted: 2022-11-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Mothers 18-40 years of age
• Infants 0-24 weeks of age
• Infants who have not yet been introduced to complementary foods and beverages
• Dyads are breast- and bottle-feeding
• Mother is predominantly or solely responsible for infant feeding

Exclusion Criteria

• preterm birth (i.e., gestational age <37 weeks)
• low birth weight (<2500 g)
• maternal smoking during pregnancy
• current or past medical conditions that interfere with oral feeding
• history of slow growth or failure to thrive
• weight for length percentile <5th
• diagnosed developmental delay (e.g., Down's syndrome)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bottle-feeding First, then Breastfeeding	Mode of Feeding (breastfeeding versus bottle-feeding)	Mother-infant dyads were observed while bottle-feeding expressed breast milk during their first visit to our laboratory and were observed while breastfeeding during their second visit to our laboratory.
Breastfeeding First, then Bottle-feeding	Mode of Feeding (breastfeeding versus bottle-feeding)	Mother-infant dyads were observed while breastfeeding during their first visit to our laboratory and were observed while bottle-feeding expressed breast milk during their second visit to our laboratory.

Primary Outcome Measures

Name	Time	Method
Infant Intake During the Observed Feeding (mL)	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.
Maternal Sensitivity to Infant Cues	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.

Trial Locations

Locations (1)

Healthy Kids Laboratory within the French Hospital Copeland Health Education Pavilion; 🇺🇸 San Luis Obispo, California, United States