Clinical trial NCT06593808: SOon HOme Study About Preterm Infants
Official title: SOon HOme Study. Early Open Cot Transfer in Preterm Infants, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Preterm Birth Complication
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 82
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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.

Eligibility criteria: Inclusion Criteria:

* Infants with birth weight less than 1400 grams in incubator who have reached a minimum weight of 1400 grams
* Stable clinical condition: normal heart rate and respiratory rate, No need for invasive respiratory assistance, no episodes of apnea, stable axillary temperature not less than 36.5°for at least 72 hours.
* No need for phototherapy
* Stable or increasing weight for at least 48 hours
* Signature by both parents of an informed consent

Exclusion Criteria:

* Severe congenital anomalies at birth
* Need for invasive respiratory support at the time of enrollment
* Ongoing phototherapy
* Major surgical pathology with need for surgery
* Failure by both parents to sign up for informed consent

Primary outcomes:
measure: Evaluation of average length of hospital stay of preterm infants
timeFrame: 72 hours after weaning from the incubator
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS; UOC Neonatologia
Study officials:
affiliation: Fondazione Policlinico Agostino Gemelli IRCCS
name: Francesca Priolo
role: PRINCIPAL_INVESTIGATOR
References: