Breast Versus Bottle Study

NCT03704051 | Completed Results

• 2 other identifiers: 2018-143-COR03HD096164
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding; Bottle Feeding

Keywords

infant feeding; feeding interactions; maternal feeding practices; breastfeeding; bottle-feeding

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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)

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)

Interventions

Mode of Feeding (breastfeeding versus bottle-feeding) BEHAVIORAL

Infants will be breastfed during one lab visit and bottle-fed (with expressed breast-milk) during the other.

Bottle-feeding First, then Breastfeeding; Breastfeeding First, then Bottle-feeding

Eligibility Criteria

• Age: 0 Weeks - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• California Polytechnic State University-San Luis Obispo: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Healthy Kids Laboratory within the French Hospital Copeland Health Education Pavilion

San Luis Obispo, California, 93401, United States

Location

Related Publications (1)

• 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.

  PMID: 33939269 RESULT

MeSH Terms

Conditions

Breast Feeding; Bottle Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Limitations and Caveats

This study consisted of mothers who were exclusively or predominantly breastfeeding and who fed expressed breast milk (not formula) when bottle-feeding.

Results Point of Contact

• Title: Dr. Alison Ventura
• Organization: California Polytechnic State University

akventur@calpoly.edu

(805) 756-5693

Study Officials

• Alison K Ventura, PhD

  Cal Poly

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 12, 2018
• Study Start: October 15, 2018
• Primary Completion: March 15, 2020
• Study Completion: July 1, 2021
• Last Updated: February 28, 2024
• Results First Posted: November 15, 2022

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)