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

October 20, 2024 updated by: Mireia Pascual Tutusaus, University of Barcelona

Randomized Control Trial to Evaluate a 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08008
        • Rosselló 230
      • Barcelona, Spain, 08028
        • C/Sabino de Arana, 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: CONTROL GROUP
The Control Group receives the usual intervention from the health center, that consists in breastfeeding support in the NICU 1 time/week until hospital discharge.
Experimental: EXPERIMENTAL GROUP
The Experimental Group receives the PAP-LM programme.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BREASTFEEDING RATES
Time Frame: 15 days postpartum, at 3 months and at 6 months postpartum
Exclusive Breastfeeding or Parcial Breastfeeding
15 days postpartum, at 3 months and at 6 months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PREMATURE GROWTH
Time Frame: 15 days postpartum, at 3 and 6 months postpartum
Kilograms, percentiles and Z-scores of weight
15 days postpartum, at 3 and 6 months postpartum
PREMATURE HEIGHT
Time Frame: 15 days postpartum, at 3 and 6 months postpartum
Meters, percentiles and Z-scores of height
15 days postpartum, at 3 and 6 months postpartum
PREMATURE CRANIAL PERIMETER
Time Frame: 15 days postpartum, at 3 and 6 months postpartum
Meters, percentiles and Z-scores of head circumference
15 days postpartum, at 3 and 6 months postpartum
PUNTUATION IN DEVELOPMENT WITH ASQ-3
Time Frame: At 6 months postpartum
Total puntuation in Ages And Stages Questionnarie of Development (ASQ-3)
At 6 months postpartum
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.
15 days postpartum and at 6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

Investigators

  • Principal Investigator: MIREIA PASCUAL, HOSPITAL CLÍNIC I PROVINICIAL DE BARCELONA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2021

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

March 20, 2024

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

October 20, 2024

First Posted (Actual)

October 22, 2024

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 20, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2021/0595

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The information will be confidential. Participation in the study will be voluntary and optional. Participants may leave the study at any time. No data or results will be transferred to patients.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prematurity

Clinical Trials on Programme to Support Breastfeeding

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe