Randomized Control Trial to Evaluate a Breastfeeding Support and Promotion Program to Improve the Health of Premature Babies (PAP-LM)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Barcelona
- Enrollment
- 162
- Locations
- 2
- Primary Endpoint
- BREASTFEEDING RATES
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
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 GROUP
The Experimental Group receives the PAP-LM programme.
Intervention: Programme to Support Breastfeeding (Other)
Outcomes
Primary Outcomes
BREASTFEEDING RATES
Time Frame: 15 days postpartum, at 3 months and at 6 months postpartum
Exclusive Breastfeeding or Parcial Breastfeeding
Secondary Outcomes
- PREMATURE GROWTH(15 days postpartum, at 3 and 6 months postpartum)
- PREMATURE HEIGHT(15 days postpartum, at 3 and 6 months postpartum)
- PREMATURE CRANIAL PERIMETER(15 days postpartum, at 3 and 6 months postpartum)
- PUNTUATION IN DEVELOPMENT WITH ASQ-3(At 6 months postpartum)
- MOTHER EFFICACY WITH BREASTFEEDING (USING BSES)(15 days postpartum and at 6 months postpartum)
Investigators
Mireia Pascual Tutusaus
Principal Investigator
University of Barcelona