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.

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Key information

Conditions

Breastfeeding Behavior Bottle Feeding Breast Feeding Feeding Behavior

Age range

0 week–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Healthy Kids Laboratory within the French Hospital Copeland Health Education Pavilion

San Luis Obispo, California, 93401, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

Infant Intake During the Observed Feeding (mL)

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

California Polytechnic State University-San Luis Obispo

Other

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2021
First posted: Oct 12, 2018
Registry last updated: Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed