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Clinical Trials/NCT03704051
NCT03704051
Completed
N/A

Breast Versus Bottle Study

California Polytechnic State University-San Luis Obispo1 site in 1 country94 target enrollmentOctober 15, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breastfeeding
Sponsor
California Polytechnic State University-San Luis Obispo
Enrollment
94
Locations
1
Primary Endpoint
Infant Intake During the Observed Feeding (mL)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2018
End Date
July 1, 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
California Polytechnic State University-San Luis Obispo
Responsible Party
Principal Investigator
Principal Investigator

Alison Ventura

Associate Professor

California Polytechnic State University-San Luis Obispo

Eligibility Criteria

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)

Outcomes

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.

Study Sites (1)

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