Promoting Lactation Education, Access, and Support Efforts for Preterm Infants (PLEASE)

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Breastfeeding

Treatments: Other: Specialized Preterm Infant/Mother Dyad Lactation Support

Study type: Interventional

Funder types: Other

Identifiers

NCT02349464

HR#27878

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Intervention

Active Comparator group

Description:

For infants receiving pediatric care at one of the seven intervention practices, mothers will receive the Specialized Preterm Infant/Mother Dyad Lactation Support which includes home equipment and pediatric clinic-lactation support to support lactation for four months post-hospital discharge.

Treatment:

Other: Specialized Preterm Infant/Mother Dyad Lactation Support

Control

No Intervention group

Description:

For infants receiving pediatric care at one of the seven control practices, mothers will receive standard support.