SOon HOme Study About Preterm Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Weaning from the incubator to open coat at a weight greater than or equal to 1400 grams.
- Who it may be relevant to
- Registry conditions: Preterm Birth Complication. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SOon HOme Study. Early Open Cot Transfer in Preterm Infants, a Randomized Controlled Trial
Overview
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.
Interventions
- Procedure Weaning from the incubator to open coat at a weight greater than or equal to 1400 grams
They will be dressed in a woolen hat and dress, wrapped in a blanket and placed in crib with preheated mattress.Vital signs will be monitored daily.Axillary temperature will be measured every 3 hours for the first 12 hours, if above or equal to 36.5°C it will be measured every 6 hours for the next 36 hours. If normothermia for 48 hours, the preheated mattress will be turned off and temperature monitoring will be continued every 3 hours for 24 hours.If greater than or equal to 36.5°C, thermal con
Primary outcome measures
- Evaluation of average length of hospital stay of preterm infants [Time frame: 72 hours after weaning from the incubator]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS; UOC Neonatologia — Roma
Identifiers
NCT: NCT06593808 · 6575