Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653595
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-05
Brief Title:
Breastfeeding Support and Promotion Program to Improve the Health of Premature Babies PAP-LM
Sponsor:
None
Organization:
None
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:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None