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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02349464
Acronym
PLEASE
Enrollment
70
Registered
2015-01-29
Start date
2014-12-31
Completion date
2018-04-30
Last updated
2018-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding

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.

Interventions

OTHERSpecialized Preterm Infant/Mother Dyad Lactation Support

Mother will receive home equipment and pediatric clinic lactation support.

Sponsors

Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Preterm infant intake of mother's milk post-hospital discharge measured by survey.4 months

Secondary

MeasureTime frame
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
Preterm infant breastfeeding post-hospital discharge measured by survey.4 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 re-hospitalization post-hospital discharge collected from pediatric clinic medical record.6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026