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

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

Study Overview

• Status: Completed
• Conditions: Breastfeeding
• Intervention / Treatment: Other: Specialized Preterm Infant/Mother Dyad Lactation Support

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; 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.	Other: Specialized Preterm Infant/Mother Dyad Lactation Support; Mother will receive home equipment and pediatric clinic lactation support.
No Intervention: Control; For infants receiving pediatric care at one of the seven control practices, mothers will receive standard support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Preterm infant intake of mother's milk post-hospital discharge measured by survey.	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Sarah N Taylor, MD, MSCR, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: January 15, 2015
• First Submitted That Met QC Criteria: January 23, 2015
• First Posted (Estimate): January 29, 2015

Study Record Updates

• Last Update Posted (Actual): June 13, 2018
• Last Update Submitted That Met QC Criteria: June 12, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: HR#27878