Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-02-09 @ 4:53 PM
Study NCT ID:
NCT06653595
Status:
COMPLETED
Last Update Posted:
2024-10-22
First Post:
2024-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breastfeeding Support and Promotion Program to Improve the Health of Premature Babies (PAP-LM)
Sponsor:
University of Barcelona
Organization:
Study Overview
Official Title:
Randomized Control Trial to Evaluate a Breastfeeding Support and Promotion Program to Improve the Health of Premature Babies (PAP-LM)
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAP-LM
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: