Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-13 @ 3:30 PM
Study NCT ID:
NCT06593808
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SOon HOme Study About Preterm Infants
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
Official Title:
SOon HOme Study. Early Open Cot Transfer in Preterm Infants, a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
SOHO
Brief Summary:
The goal of this randomized controlled trial without medication neither device (for procedure) is to compare the average length of hospital stay of infants weaned from the incubator at a weight greater than or equal to 1400 grams versus infants weaned at a weight greater than or equal to 1600 grams.
The main questions it aims to answer are:
* Is it possible to reduce the average hospital stay in the early weaning group compared with the standard weaning group?
* Is this procedure safe and without adverse outcomes between the two groups during the hospital stay and during the first week after discharge?
The main questions it aims to answer are:
* Is it possible to reduce the average hospital stay in the early weaning group compared with the standard weaning group?
* Is this procedure safe and without adverse outcomes between the two groups during the hospital stay and during the first week after discharge?
Detailed Description:
Premature or low-birth-weight infants have low thermoregulatory abilities, higher risk of hypothermia and thus require a heated environment to survive. In the Neonatal Intensive Care Unit, these infants are placed from birth in an appropriately heated and humidified incubator. When they gain thermal competence they are gradually transferred to the open crib, normally when they reach a weight of about 1600-1800 grams, although the practice varies widely among neonatal units. Recent studies have concluded that clinically stable preterm infants can be transferred to an open crib at a body weight of less than 1600 grams. The abilities to maintain a normal body temperature in an open crib, good feeding autonomy, stable cardio-respiratory function, and acceptable growth rate are the physiological skills generally required for discharge of infants from the hospital.
The study compares the average length of hospital stay of infants weaned from the incubator at a weight greater than or equal to 1400 grams versus infants weaned at a weight greater than or equal to 1600 grams, as well as the incidence of adverse outcomes between the two groups (lower growth rate, inadequate breastfeeding, thermal lability and need for the incubator, readmission to the hospital) during the ward stay and during the first week after discharge, the degree of psychological stress of the parents, and the quality of the parent-child relationship in the two different groups.
The study compares the average length of hospital stay of infants weaned from the incubator at a weight greater than or equal to 1400 grams versus infants weaned at a weight greater than or equal to 1600 grams, as well as the incidence of adverse outcomes between the two groups (lower growth rate, inadequate breastfeeding, thermal lability and need for the incubator, readmission to the hospital) during the ward stay and during the first week after discharge, the degree of psychological stress of the parents, and the quality of the parent-child relationship in the two different groups.
Study Oversight
Has Oversight DMC:
None
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?: