Status:
NOT_YET_RECRUITING
SOon HOme Study About Preterm Infants
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Preterm Birth Complication
Eligibility:
All Genders
Phase:
NA
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 greate...
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 infan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT06593808
Start Date
October 1 2024
End Date
February 28 2026
Last Update
September 19 2024
Active Locations (1)
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1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS; UOC Neonatologia
Roma, Italy, 00168