Breast Versus Bottle Study

California Polytechnic State University-San Luis Obispo94 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Breastfeeding 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.

Eligibility

Sex: ALLMin age: 0 WeeksMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Healthy Kids Laboratory within the French Hospital Copeland Health Education Pavilion

San Luis Obispo, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 2-hour period

Data from ClinicalTrials.gov

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