Skip to main content
Clinical Trials/NCT06358729
NCT06358729
Enrolling by Invitation
N/A

The Impact of Pre-Pregnancy Weight Loss on Infant Sucking Behavior in Response to a Challenging Nipple

University of Michigan1 site in 1 country30 target enrollmentFebruary 13, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity; Familial
Sponsor
University of Michigan
Enrollment
30
Locations
1
Primary Endpoint
Suck effect
Status
Enrolling by Invitation
Last Updated
last year

Overview

Brief Summary

This study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes. Researchers guess that infants of mothers with obesity who did not lose weight prior to pregnancy will have the greatest Suck Effect on the challenging compared with the typical nipple.

Detailed Description

The researchers will recruit babies from the original cohort in the PLAN study (NCT03244722), regardless of which arms they participated in. However, the researchers will test the study arms from the original PLAN study for effects on the study's dependent variables. Their between-subjects arms included Pre-pregnancy obesity with intensive weight loss intervention, pre-pregnancy obesity with standard of care intervention, and pre-pregnancy healthy weight with no intervention. So, although the researchers are not assigning babies to any arms, their original assignment will still be assessed the study analysis.

Registry
clinicaltrials.gov
Start Date
February 13, 2025
End Date
April 2027
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amanda Kinney Crandall

Research Fellow, Pediatrics

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Suck effect

Time Frame: Up to 6 weeks

Sucking will be measured with the NFANT® Feeding Solution

Secondary Outcomes

  • Total Night Wake-ups within 24 hours of intervention(Up to 6 weeks)
  • Milk/Formula consumption rate(Up to 6 weeks)
  • Sucking pressure(Up to 6 weeks)
  • Sucking frequency(Up to 6 weeks)
  • Milk/Formula intake(Up to 6 weeks)
  • Number of Feedings Over 24 Hours(Up to 6 weeks)
  • Total Hours of Sleep per 24 Hours within 24 hours of intervention(Up to 6 weeks)

Study Sites (1)

Loading locations...

Similar Trials