SOon HOme Study About Preterm Infants

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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?

Eligibility criteria

Qualifiers

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

Disqualifiers

Severe congenital anomalies at birth

Need for invasive respiratory support at the time of enrollment

Ongoing phototherapy

Major surgical pathology with need for surgery

Trial design

Treatments tested in this trial

  • Weaning from the incubator to open coat at a weight greater than or equal to 1400 grams

Treatment groups

82 Participants
are divided into 2 treatment groups