Breast Versus Bottle Study

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.

Study Overview

• Status: Completed
• Conditions: Breastfeeding; Bottle Feeding
• Intervention / Treatment: Behavioral: Mode of Feeding (breastfeeding versus bottle-feeding)

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• United States
  • California
    • San Luis Obispo, California, United States, 93401
      • Healthy Kids Laboratory within the French Hospital Copeland Health Education Pavilion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

A convenience sample of mother-infant dyads residing within 50 miles of California Polytechnic State University.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breastfeeding First, then 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.	Behavioral: 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.
Bottle-feeding First, then Breastfeeding; 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant Intake During the Observed Feeding (mL)	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.	2-hour period
Maternal Sensitivity to Infant Cues	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.	2-hour period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological Synchrony	During each feeding observation, we will also assess both the mothers' and the infant's physiological response (i.e., heart rate variability) to the feeding using electrocardiogram (ECG; BioPac MP160 data acquisition system, BioPac Systems, Inc., Goleta, CA). Two disposable pediatric electrodes will be placed on the infant's chest and one electrode will be placed on the infant's back immediately prior to the start of each feeding. Three disposable electrodes will be placed on the mother's chest immediately prior to the start of each feeding. All electrodes will be wireless and will be placed at least 5 minutes prior to the feeding to allow mothers and infants to become acclimated. Our main variable of interest will be maternal and infant heart rate variability, assessed by estimating inter-beat-intervals (IBI) to determine variation in R-R intervals of the heartbeat during the feeding.	2-hour period

Collaborators and Investigators

• Sponsor: California Polytechnic State University-San Luis Obispo
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Alison K Ventura, PhD, Cal Poly

Publications and helpful links

General Publications

• Ventura A, Hupp M, Lavond J. Mother-infant interactions and infant intake during breastfeeding versus bottle-feeding expressed breast milk. Matern Child Nutr. 2021 Oct;17(4):e13185. doi: 10.1111/mcn.13185. Epub 2021 May 3.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: breastfeeding; infant feeding; maternal feeding practices; feeding interactions; bottle-feeding
• Other Study ID Numbers: 2018-143-CO; R03HD096164 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not currently plan to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No