Breast Versus Bottle Study

Study Overview
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Brief Summary
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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.

Official Title
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Breast Versus Bottle Study

Conditions
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Breastfeeding, Bottle Feeding

Intervention / Treatment
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* Behavioral: Mode of Feeding (breastfeeding versus bottle-feeding)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 0 Weeks
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breastfeeding First, then Bottle-feeding<br>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)<br>* Infants will be breastfed during one lab visit and bottle-fed (with expressed breast-milk) during the other.<br>|
| Bottle-feeding First, then Breastfeeding<br>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)<br>* Infants will be breastfed during one lab visit and bottle-fed (with expressed breast-milk) during the other.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant feeding, feeding interactions, maternal feeding practices, breastfeeding, bottle-feeding