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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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.

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Preterm infants in incubatorNo intervention 0 interventions
Group B: Preterm infants in open coatExperimental treatment 1 intervention

Trial outcomes

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

Time frame
72 hours after weaning from the incubator

Secondary outcomes

Other outcomes

Sponsors and contacts

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