SOon HOme Study About Preterm Infants

NCT ID: NCT06593808

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-02-28

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.

Conditions

Preterm Birth Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Preterm infants in incubator

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Preterm infants in open coat

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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 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.

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesca Priolo

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Agostino Gemelli IRCCS

Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; UOC Neonatologia

Roma, , Italy

Countries

Italy

Central Contacts

Francesca Priolo

Role: CONTACT

francesca.priolo@policlinicogemelli.it

+390630154357

Facility Contacts

Francesca Priolo

Role: primary

francesca.priolo@policlinicogemelli.it

+390630154357

Claudia Fè

Role: backup

claudia.fe@policlinicogemelli.it

+390630154357

Other Identifiers

6575

Identifier Type: -

Identifier Source: org_study_id