SOon HOme Study About Preterm Infants

NCT06593808 | Not Yet Recruiting

• 1 other identifier: 6575
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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?

Conditions

Preterm Birth Complication

Outcome Measures

Primary Outcomes (1)

• Evaluation of average length of hospital stay of preterm infants

  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

  72 hours after weaning from the incubator

Study Arms (2)

Preterm infants in incubator

NO INTERVENTION

Preterm infant in stable conditions transferred from the incubator to the open crib at a weight greater than or equal to 1600 grams

Preterm infants in open coat

EXPERIMENTAL

Preterm infant in stable conditions transferred from the incubator to the open crib at a weight greater than or equal to 1400 grams

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

Interventions

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

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 control will be continued every 8 hours for 48 hours, at the end of which time, if normothermic, care will be confirmed.If not it will be placed back in the crib with heated mattress.If temperature still below 36.5°C, an additional blanket will be placed and it will be rechecked after 2 hours.If it remains below 36.5°C, the infant will be placed under a radiant lamp and the temperature will be checked after 3 hours.If hypothermia persists, the infant will be transferred back to the incubator.

Preterm infants in open coat

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; UOC Neonatologia

Roma, 00168, Italy

Location

Study Officials

• Francesca Priolo

  Fondazione Policlinico Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Priolo

CONTACT

+390630154357; francesca.priolo@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IT (1)