Hypothermia, NewbornNCT06230172
Early Weaning From Incubator To Crib
A study testing Weaning incubator (heat) at an lower postnatal weight in people with Hypothermia, Newborn and Body Temperature Changes, run by Augusta University at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and feasibility of weaning from the incubator at a lower post-natal weight at 1600 grams. Our hypothesis is that early weaning from the incubator to a crib/bassinet is safe and may result in a decrease in length of hospital stay while maintaining appropriate growth… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypothermia, Newborn, Body Temperature Changes, Newborn Thermal Injury
- What is being tested?
- Weaning incubator (heat) at an lower postnatal weight
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2023to 21 Jul 2024
- 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 a birth weight <1600 gm
Who cannot join
- Infants who have bradycardia (HR<80 bpm) that require stimulation for resolution.
- Infants who require phototherapy.
- Infants who require respiratory support >2 liter per minute flow by nasal cannula, oxygen need can vary between 21-100%.
- Infants with major congenital anomalies
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30912
Victor M Ayulo, MD, 912-816-2144, vayulo@augusta.edu
About this study
Official title: Early Weaning of Infants Less Than 1800 Grams From Incubator To Crib
The purpose of this study is to determine the safety and feasibility of weaning from the incubator at a lower post-natal weight at 1600 grams. Our hypothesis is that early weaning from the incubator to a crib/bassinet is safe and may result in a decrease in length of hospital stay while maintaining appropriate growth velocity. Specific outcomes the investigators will evaluate are the length of hospital stay and growth velocity at early weaning.
- Being tested
- Weaning incubator (heat) at an lower postnatal weight
- Medical subject headings
- Hypothermia, Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weaning incubator (heat) at an lower postnatal weightRadiation
Infants in the intervention group are weaned in the same manner as the infants in the control arm; however, the wean begins at a lower postnatal weight.
Our institutional guidelines for weaning infants from incubator to crib was unchanged for both groups.
| Study group | Role | What they receive |
|---|---|---|
| Prospective group (>1600 grams) | Experimental | The prospective group is weaned from incubator to crib at a postnatal weight of >1600 grams following consent process. Receives: Radiation: Weaning incubator (heat) at an lower postnatal weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Duration of hospital stay
Measured: From birth date to hospital discharge, assessed up to 52 weeks
Secondary outcomes (1)
Growth velocity
Weight gain following wean from incubator to crib
Measured: From birth date to hospital discharge, assessed up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start21 Jul 2023
- Primary completion21 Jul 2024 (estimated)
- Study completion21 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypothermia, NewbornStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The investigators will compare a retrospective control arm with a prospective intervention arm.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230172
- Sponsor's protocol ID
- 1944411
- Status last verified
- Feb 2024
- First submitted
- 4 Oct 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zecca E, Corsello M, Priolo F, Tiberi E, Barone G, Romagnoli C. Early weaning from incubator and early discharge of preterm infants: randomized clinical trial. Pediatrics. 2010 Sep;126(3):e651-6. doi: 10.1542/peds.2009-3005. Epub 2010 Aug 9.
PubMed 20696729Shankaran S, Bell EF, Laptook AR, Saha S, Newman NS, Kazzi SNJ, Barks J, Stoll BJ, Bara R, Gabrio J, Childs K, Das A, Higgins RD, Carlo WA, Sanchez PJ, Carlton DP, Pavageau L, Malcolm WF, D'Angio CT, Ohls RK, Poindexter BB, Sokol GM, Van Meurs KP, Colaizy TT, Khmour A, Puopolo KM, Garg M, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health, and Human Development Neonatal Research Network. Weaning of Moderately Preterm Infants from the Incubator to the Crib: A Randomized Clinical Trial. J Pediatr. 2019 Jan;204:96-102.e4. doi: 10.1016/j.jpeds.2018.08.079. Epub 2018 Oct 15.
PubMed 30337189
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Weaning of Infants Less Than 1800 Grams From Incubator To Crib
- ClinicalTrials.gov ID
- NCT06230172
- Acronym / sponsor ID
- 1944411
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 21 Jul 2024 (estimated)
- Study completion
- 21 Jul 2024 (estimated)
- First posted
- 30 Jan 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 purpose of this study is to determine the safety and feasibility of weaning from the incubator at a lower post-natal weight at 1600 grams. Our hypothesis is that early weaning from the incubator to a crib/bassinet is safe and may result in a decrease in length of hospital stay while maintaining appropriate growth velocity. Specific outcomes the investigators will evaluate are the length of hospital stay and growth velocity at early weaning.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigators will compare a retrospective control arm with a prospective intervention arm.
| Arm | Type | Receives |
|---|---|---|
| Prospective group (>1600 grams) | Experimental | Radiation: Weaning incubator (heat) at an lower postnatal weightThe prospective group is weaned from incubator to crib at a postnatal weight of >1600 grams following consent process. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Infants with a birth weight <1600 gm
Key exclusion criteria (4 listed)
- Infants who have bradycardia (HR<80 bpm) that require stimulation for resolution.
- Infants who require phototherapy.
- Infants who require respiratory support >2 liter per minute flow by nasal cannula, oxygen need can vary between 21-100%.
- Infants with major congenital anomalies
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 incubator (heat) at an lower postnatal weightInfants in the intervention group are weaned in the same manner as the infants in the control arm; however, the wean begins at a lower postnatal weight. Our institutional guidelines for weaning infants from incubator to crib was unchanged for both groups. | Radiation | Prospective group (>1600 grams) |
Primary outcome
Length of hospital stay
Time frame: From birth date to hospital discharge, assessed up to 52 weeks
Duration of hospital stay
1 secondary outcome
Growth velocity
Time frame: From birth date to hospital discharge, assessed up to 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 20696729Zecca E, Corsello M, Priolo F, Tiberi E, Barone G, Romagnoli C. Early weaning from incubator and early discharge of preterm infants: randomized clinical trial. Pediatrics. 2010 Sep;126(3):e651-6. doi: 10.1542/peds.2009-3005. Epub 2010 Aug 9.
- Background: PubMed 30337189Shankaran S, Bell EF, Laptook AR, Saha S, Newman NS, Kazzi SNJ, Barks J, Stoll BJ, Bara R, Gabrio J, Childs K, Das A, Higgins RD, Carlo WA, Sanchez PJ, Carlton DP, Pavageau L, Malcolm WF, D'Angio CT, Ohls RK, Poindexter BB, Sokol GM, Van Meurs KP, Colaizy TT, Khmour A, Puopolo KM, Garg M, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health, and Human Development Neonatal Research Network. Weaning of Moderately Preterm Infants from the Incubator to the Crib: A Randomized Clinical Trial. J Pediatr. 2019 Jan;204:96-102.e4. doi: 10.1016/j.jpeds.2018.08.079. Epub 2018 Oct 15.
- Individual participant dataSharing planned: No
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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.
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 incubator (heat) at an lower postnatal weight in people with Hypothermia, Newborn and Body Temperature Changes, run by Augusta University at 1 site in United States.
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 1 inclusion and 4 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 7 Feb 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 United States. 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 Victor M Ayulo, MD (9128162144, vayulo@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: From birth date to hospital discharge, assessed up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06230172, which also lists 2 linked publications.
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 7 Feb 2024.