Skip to main content
Clinical Trials/NCT02349464
NCT02349464
Completed
Not Applicable

Promoting Lactation Education, Access, and Support Efforts for Preterm Infants

Medical University of South Carolina0 sites70 target enrollmentDecember 2014
ConditionsBreastfeeding

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breastfeeding
Sponsor
Medical University of South Carolina
Enrollment
70
Primary Endpoint
Preterm infant intake of mother's milk post-hospital discharge measured by survey.
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is to determine whether a post-hospital discharge lactation support system increases preterm infant intake of mother's milk.

Detailed Description

Preterm infants have barriers to successful breastfeeding that include oral feeding immaturity and high nutritional needs. Therefore, successful preterm infant breastfeeding requires increased counseling and equipment support compared to full-term infant breastfeeding. Inpatient preterm infant care has responded to these barriers, with specialized preterm infant lactation support. Unfortunately, for preterm infants, the onset of feeding maturity often coincides with hospital discharge and, therefore, inpatient, specialized lactation support ends just as the infant initiates nutritive feeding at the breast. Therefore, the success of preterm infant breastfeeding relies on the home environment and the community pediatric caregivers. A program has been created to provide this specialized preterm infant/mother outpatient lactation support. The program includes in-home availability of a hospital-grade electric pump and an infant weigh scale and pediatric clinic-based lactation counseling support. Fourteen pediatric practices are included in this study. Seven practices were randomized to intervention and seven were randomized to be controls.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
April 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Any infant discharge to home from the Medical University of South Carolina neonatal services
  • Born \<35 weeks' gestation
  • Mother providing her milk and plans to continue providing her milk for at least 6 months
  • The infant's post-discharge pediatric clinic identified by mother as one involved in the study
  • The eligible twin will be the first twin discharged from the hospital or, if discharge occurs simultaneously, the infant identified in the hospital as "twin A" will be eligible.

Exclusion Criteria

  • Infants with major congenital anomalies
  • Infants with anomalies affecting oral intake
  • Infants receiving tube feeds at hospital discharge
  • Infants receiving parenteral nutrition at hospital discharge
  • Triplet or greater pregnancies
  • Twin of the one enrolled twin will not be eligible.

Outcomes

Primary Outcomes

Preterm infant intake of mother's milk post-hospital discharge measured by survey.

Time Frame: 4 months

Secondary Outcomes

  • Preterm infant re-hospitalization post-hospital discharge collected from pediatric clinic medical record.(6 months)
  • Preterm infant respiratory illness events post-hospital discharge collected from pediatric clinic medical record.(6 months)
  • Preterm infant gastrointestinal illness events post-hospital discharge collected from pediatric clinic medical record.(6 months)
  • Preterm infant breastfeeding post-hospital discharge measured by survey.(4 months)
  • Sustaining preterm infant mother's milk intake post-hospital discharge measured by survey.(6 months)
  • Preterm infant growth post-hospital discharge collected from pediatric clinic medical record.(6 months)

Similar Trials