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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06653595
Acronym
PAP-LM
Enrollment
162
Registered
2024-10-22
Start date
2021-10-13
Completion date
2024-03-20
Last updated
2024-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity, Prematurity; Extreme

Keywords

IBCLC, advance practice nurse, best practice, breastfeeding rates, breastfeeding outcomes, interventions

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.

Interventions

OTHERProgramme 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.

Sponsors

University of Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

We will be use the random.org program to randomize families into two groups: experimental group (which will receive the intervention) and control group (which will receive usual care).The experimental group intervention will include: 1 pre-discharge face-to-face session, 8 home sessions until 4 months, and 3 telephone sessions until the baby is 6 months old. All sessions will be conducted by an Advanced Practice Nurse and IBCLC Expert in breastfeeding issues.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
BREASTFEEDING RATES15 days postpartum, at 3 months and at 6 months postpartumExclusive Breastfeeding or Parcial Breastfeeding

Secondary

MeasureTime frameDescription
PREMATURE GROWTH15 days postpartum, at 3 and 6 months postpartumKilograms, percentiles and Z-scores of weight
PREMATURE HEIGHT15 days postpartum, at 3 and 6 months postpartumMeters, percentiles and Z-scores of height
PREMATURE CRANIAL PERIMETER15 days postpartum, at 3 and 6 months postpartumMeters, percentiles and Z-scores of head circumference
PUNTUATION IN DEVELOPMENT WITH ASQ-3At 6 months postpartumTotal puntuation in Ages And Stages Questionnarie of Development (ASQ-3)
MOTHER EFFICACY WITH BREASTFEEDING (USING BSES)15 days postpartum and at 6 months postpartumThe 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026