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

University of Barcelona162 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

162

Conditions

Prematurity; Extreme Prematurity

Interventions

Programme to Support BreastfeedingOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Rosselló 230

Barcelona, Spain

C/Sabino de Arana, 1

Barcelona, Spain

Outcomes

Primary Outcomes

BREASTFEEDING RATES

Exclusive Breastfeeding or Parcial Breastfeeding

Time frame: 15 days postpartum, at 3 months and at 6 months postpartum

Secondary Outcomes

PREMATURE GROWTH

Kilograms, percentiles and Z-scores of weight

Time frame: 15 days postpartum, at 3 and 6 months postpartum

PREMATURE HEIGHT

Meters, percentiles and Z-scores of height

Time frame: 15 days postpartum, at 3 and 6 months postpartum

PREMATURE CRANIAL PERIMETER

Meters, percentiles and Z-scores of head circumference

Time frame: 15 days postpartum, at 3 and 6 months postpartum

PUNTUATION IN DEVELOPMENT WITH ASQ-3

Total puntuation in Ages And Stages Questionnarie of Development (ASQ-3)

Time frame: At 6 months postpartum

MOTHER EFFICACY WITH BREASTFEEDING (USING BSES)

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.

Time frame: 15 days postpartum and at 6 months postpartum

Data from ClinicalTrials.gov

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