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

Not Applicable

Completed

• Conditions: Prematurity; Extreme; Prematurity

• Registration Number: NCT06653595
• Lead Sponsor: University of Barcelona

Brief 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.

Study Timeline

• Study Start: 2021-10-13
• Primary Completion: 2024-02-15
• Study Completion: 2024-03-20
• Study First Submitted: 2024-06-05
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-20
• Last Update Submitted: 2024-10-20
• Study First Posted: 2024-10-22
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 162

Inclusion Criteria

• Moderate premature
• Late premature babies
• Admitted to the NICU of Hospital Clínic
• Single pregnancy
• Families residing in the Barcelona Metropolitan Area (AMB)
• Families with a good mental health
• Families with a desire for Exclusive Breastfeeding up to 6 months

Exclusion Criteria

• Maternal diseases that contraindicate breastfeeding
• Mothers with a history of breast surgery
• Mothers with a history of severe hypogalactia
• Premature babies with severe complications
• Premature babies diagnosed with severe CIR

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
BREASTFEEDING RATES	15 days postpartum, at 3 months and at 6 months postpartum	Exclusive Breastfeeding or Parcial Breastfeeding

Secondary Outcome Measures

Name	Time	Method
PREMATURE GROWTH	15 days postpartum, at 3 and 6 months postpartum	Kilograms, percentiles and Z-scores of weight
PREMATURE HEIGHT	15 days postpartum, at 3 and 6 months postpartum	Meters, percentiles and Z-scores of height
PREMATURE CRANIAL PERIMETER	15 days postpartum, at 3 and 6 months postpartum	Meters, percentiles and Z-scores of head circumference
PUNTUATION IN DEVELOPMENT WITH ASQ-3	At 6 months postpartum	Total puntuation in Ages And Stages Questionnarie of Development (ASQ-3)
MOTHER EFFICACY WITH BREASTFEEDING (USING BSES)	15 days postpartum and at 6 months postpartum	The Breastfeeding Self-Efficacy Scale (BSES) is a tool that helps assess how confident a mother feels about her ability to breastfeed. Based on the idea that believing in yourself impacts success, the scale uses 14 questions to measure a mother's sense of capability in different breastfeeding tasks. The higher her score, the more confident she feels. This scale is commonly used by healthcare providers and researchers to better understand where mothers might need extra support, as confidence plays a key role in how long and how successfully they continue breastfeeding.

Trial Locations

Locations (2)

Rosselló 230; 🇪🇸 Barcelona, Spain

C/Sabino de Arana, 1; 🇪🇸 Barcelona, Spain