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

University of Barcelona

Status: Completed

Conditions: Prematurity; Prematurity; Extreme

Treatments: Other: Programme to Support Breastfeeding

Study type: Interventional

Funder types: Other

Identifiers

NCT06653595

HCB/2021/0595

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

CONTROL GROUP

No Intervention group

Description:

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

Experimental group

Description:

The Experimental Group receives the PAP-LM programme.

Treatment:

Other: Programme to Support Breastfeeding