Preterm Birth ComplicationSOHONCT06593808
SOon HOme Study About Preterm Infants
A study testing Weaning from the incubator to open coat at a weight greater than or equal to 1400 grams in people with Preterm Birth Complication, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm Birth Complication
- What is being tested?
- Weaning from the incubator to open coat at a weight greater than or equal to 1400 grams
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS; UOC Neonatologia
Roma, 00168
Francesca Priolo, +390630154357, francesca.priolo@policlinicogemelli.it
Claudia Fè, +390630154357, claudia.fe@policlinicogemelli.it
About this study
Official title: SOon HOme Study. Early Open Cot Transfer in Preterm Infants, a Randomized Controlled 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?
Read the 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
- Being tested
- Weaning from the incubator to open coat at a weight greater than or equal to 1400 grams
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weaning from the incubator to open coat at a weight greater than or equal to 1400 gramsProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Weaning from the incubator to open coat at a weight greater than or equal to 1400 grams |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours after weaning from the incubator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Birth ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca Priolo, Principal investigator, Fondazione Policlinico Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593808
- Sponsor's protocol ID
- 6575
- Acronym
- SOHO
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOon HOme Study. Early Open Cot Transfer in Preterm Infants, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06593808
- Acronym / sponsor ID
- SOHO / 6575
- Conditions
- Preterm Birth Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Weaning from the incubator to open coat at a weight greater than or equal to 1400 gramsPreterm infant in stable conditions transferred from the incubator to the open crib at a weight greater than or equal to 1400 grams |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weaning from the incubator to open coat at a weight greater than or equal to 1400 gramsThey 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. | Procedure or surgery | Preterm infants in open coat |
Primary outcome
Evaluation of average length of hospital stay of preterm infants
Time frame: 72 hours after weaning from the incubator
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesca Priolo principal investigator
Fondazione Policlinico Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weaning from the incubator to open coat at a weight greater than or equal to 1400 grams in people with Preterm Birth Complication, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesca Priolo (+390630154357, francesca.priolo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of average length of hospital stay of preterm infants (time frame: 72 hours after weaning from the incubator). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.