Clinical trial NCT06653595: Breastfeeding Support and Promotion Program to Improve the Health of Premature Babies (PAP-LM)
Official title: Randomized Control Trial to Evaluate a Breastfeeding Support and Promotion Program to Improve the Health of Premature Babies (PAP-LM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity; Extreme
Prematurity
Keywords: IBCLC
advance practice nurse
best practice
breastfeeding rates
breastfeeding outcomes
interventions
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: BREASTFEEDING RATES
timeFrame: 15 days postpartum, at 3 months and at 6 months postpartum
Secondary outcomes:
measure: PREMATURE GROWTH
timeFrame: 15 days postpartum, at 3 and 6 months postpartum
measure: PREMATURE HEIGHT
timeFrame: 15 days postpartum, at 3 and 6 months postpartum
measure: PREMATURE CRANIAL PERIMETER
timeFrame: 15 days postpartum, at 3 and 6 months postpartum
measure: PUNTUATION IN DEVELOPMENT WITH ASQ-3
timeFrame: At 6 months postpartum
measure: MOTHER EFFICACY WITH BREASTFEEDING (USING BSES)
timeFrame: 15 days postpartum and at 6 months postpartum
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Rosselló 230
city: Barcelona
country: Spain
facility: C/Sabino de Arana, 1
Study officials:
affiliation: HOSPITAL CLÍNIC I PROVINICIAL DE BARCELONA
name: MIREIA PASCUAL
role: PRINCIPAL_INVESTIGATOR
References:
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