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

NCT02349464 | Completed DMC

• 1 other identifier: HR#27878
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breastfeeding

Outcome Measures

Primary Outcomes (1)

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

  4 months

Secondary Outcomes (6)

• 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

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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

Interventions

Specialized Preterm Infant/Mother Dyad Lactation Support OTHER

Mother will receive home equipment and pediatric clinic lactation support.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Sarah N Taylor, MD, MSCR

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 29, 2015
• Study Start: December 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 13, 2018

Record last verified: 2018-06