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

NCT ID: NCT02349464

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2018-04-30

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.

Conditions

Breastfeeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Specialized Preterm Infant/Mother Dyad Lactation Support

Intervention Type: OTHER

Mother will receive home equipment and pediatric clinic lactation support.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Specialized Preterm Infant/Mother Dyad Lactation Support

Mother will receive home equipment and pediatric clinic lactation support.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah N Taylor, MD, MSCR

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Other Identifiers

HR#27878

Identifier Type: -

Identifier Source: org_study_id