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Clinical Trials/NCT02517970
NCT02517970CompletedNot Applicable

Observing Infant Feeding Interactions

California Polytechnic State University-San Luis Obispo2 sites in 1 country27 target enrollmentStarted: June 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
27
Locations
2
Primary Endpoint
Infant intake within a feeding (mL)

Study Overview

Brief Summary

The objective of the proposed research is to conduct a within-subject experimental study that will assess the effect of environmental distractions on a mothers' ability to recognize and feed in response to infants' feeding cues. Investigators hypothesize that mothers will spend significantly more time looking at their technology compared to looking at their infant, which will be negatively associated with the mothers' responsiveness to her infant. This will have a positive association with infant intake during the feeding. Investigators also hypothesize that mothers will show less sensitivity when distracted when compared to when they are not distracted.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
— to 6 Months (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Mothers must be 18 years or older
  • Infants must be between 0-6 months of age

Exclusion Criteria

  • Preterm birth
  • Medical conditions that interfere with feeding

Arms & Interventions

Classical Music versus Television show

Experimental

This is within-subject study; all infants will be exposed to both conditions. Order of presentation will counterbalanced across infants.

Intervention: Technology distraction (Behavioral)

Outcomes

Primary Outcomes

Infant intake within a feeding (mL)

Time Frame: 2-hour period

Infant intake within a feeding (mL) assessed by weighing the bottle or infant, depending on the type of feeding, before and after the feeding.

Maternal responsiveness

Time Frame: 2-hour period

Maternal responsiveness to infant cues during a feeding assessed by the Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale.

Secondary Outcomes

No secondary outcomes reported

Investigators

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

Alison Ventura

Assistant Professor

California Polytechnic State University-San Luis Obispo

Study Sites (2)

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