NCT06653595

Breastfeeding Support and Promotion Program to Improve the Health of Premature Babies (PAP-LM)

Randomized Control Trial to Evaluate a Breastfeeding Support and Promotion Program to Improve the Health of Premature Babies (PAP-LM)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: University of Barcelona · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effectiveness of a breastfeeding support and promotion program to increase exclusive breastfeeding rates in the preterm group. The intervention is performed by an Advanced Practice Nurse and International Board Certified Breastfeeding Consultant (IBCLC), with high expertise in breastfeeding problems. It is a combination of face-to-face, home care and telephone attention to improve the adherence to breastfeeding. The intervention lasts 6 months.

Detailed description

Will be included moderately premature infants to the Neonatal Unit of the Hospital Clínic who achieve with the inclusion criteria of the study. The sample calculation includes 162 subjects to increase breastfeeding rates to 70% at discharge, 50% at 3 months and 40% at 6 months of the babies. Mothers who wish to exclusively breastfeed up to 6 months and sign the informed consent, will be randomized into the experimental group or control group. The control group will receive usual care and the experimental group will receive 1 pre-discharge face-to-face session, 8 home care sessions up to 4 months and 3 telephone follow-up sessions up to 6 months of baby.

Conditions

• Prematurity; Extreme
• Prematurity

Interventions

Type	Name	Description
OTHER	Programme to Support Breastfeeding	The intervention consists of active support for breastfeeding by a lactation expert and IBCLC until the premature baby is 6 months old. The intervention includes: 1 face-to-face pre-discharge session, 8 home sessions up to 4 months and 3 telephone sessions up to 6 months.

Timeline

• Start date: 2021-10-13
• Primary completion: 2024-02-15
• Completion: 2024-03-20
• First posted: 2024-10-22
• Last updated: 2024-10-22

Locations

2 sites across 1 country: Spain