Breast Versus Bottle Study

Breastfeeding Clinical Trial

Official title:

Breast Versus Bottle Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704051
• Other study ID #: 2018-143-CO
• Secondary ID: R03HD096164
• Status: Completed
• Start date: October 15, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: February 2024
• Source: California Polytechnic State University-San Luis Obispo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 1, 2021
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Weeks to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bottle Feeding
• Breastfeeding

Intervention

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.

Locations

Country	Name	City	State
United States	Healthy Kids Laboratory within the French Hospital Copeland Health Education Pavilion	San Luis Obispo	California

Sponsors (2)

Lead Sponsor	Collaborator
California Polytechnic State University-San Luis Obispo	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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