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

Breastfeeding Clinical Trial

— PLEASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02349464
• Other study ID #: HR#27878
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: April 2018

Study information

• Verified date: June 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Other:
• Specialized Preterm Infant/Mother Dyad Lactation Support
Mother will receive home equipment and pediatric clinic lactation support.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm infant intake of mother's milk post-hospital discharge measured by survey.		4 months
Secondary	Preterm infant breastfeeding post-hospital discharge measured by survey.		4 months
Secondary	Sustaining preterm infant mother's milk intake post-hospital discharge measured by survey.		6 months
Secondary	Preterm infant growth post-hospital discharge collected from pediatric clinic medical record.		6 months
Secondary	Preterm infant re-hospitalization post-hospital discharge collected from pediatric clinic medical record.		6 months
Secondary	Preterm infant respiratory illness events post-hospital discharge collected from pediatric clinic medical record.		6 months
Secondary	Preterm infant gastrointestinal illness events post-hospital discharge collected from pediatric clinic medical record.		6 months