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Completed

NCT Number: NCT06653595

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

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.

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Key information

Conditions

Prematurity; Extreme Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Prematurity Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

C/Sabino de Arana, 1, Barcelona, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Programme to Support Breastfeeding

Other

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.

Primary outcomes

  1. BREASTFEEDING RATES

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

    Exclusive Breastfeeding or Parcial Breastfeeding

Secondary outcomes

  1. PREMATURE GROWTH

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

    Kilograms, percentiles and Z-scores of weight

  2. PREMATURE HEIGHT

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

    Meters, percentiles and Z-scores of height

  3. PREMATURE CRANIAL PERIMETER

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

    Meters, percentiles and Z-scores of head circumference

  4. PUNTUATION IN DEVELOPMENT WITH ASQ-3

    Time frame: At 6 months postpartum

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

  5. MOTHER EFFICACY WITH BREASTFEEDING (USING BSES)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Registry information

Official study title

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

Acronym: PAP-LM

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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