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OpenTrials
Completed

NCT Number: NCT02349464

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

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

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Specialized Preterm Infant/Mother Dyad Lactation Support

Other

Mother will receive home equipment and pediatric clinic lactation support.

Primary outcomes

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

    Time frame: 4 months

Secondary outcomes

  1. Preterm infant breastfeeding post-hospital discharge measured by survey.

    Time frame: 4 months

  2. Sustaining preterm infant mother's milk intake post-hospital discharge measured by survey.

    Time frame: 6 months

  3. Preterm infant growth post-hospital discharge collected from pediatric clinic medical record.

    Time frame: 6 months

  4. Preterm infant re-hospitalization post-hospital discharge collected from pediatric clinic medical record.

    Time frame: 6 months

  5. Preterm infant respiratory illness events post-hospital discharge collected from pediatric clinic medical record.

    Time frame: 6 months

  6. Preterm infant gastrointestinal illness events post-hospital discharge collected from pediatric clinic medical record.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Acronym: PLEASE

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2015
Registry last updated
Jun 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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