Infant, NewbornNCT02160002

Incubator Weaning of Moderately Preterm Infants

A study testing Weaning from an incubator at a lower weight (1600 grams) and Weaning from an incubator at a higher weight (1800 grams) in people with Infant, Newborn and Infant, Moderate Preterm, run by NICHD Neonatal Research Network at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this proposal is to evaluate whether weaning from an incubator to a crib at lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay among moderately preterm infants. Read more about this study

Who is it for?: Ages 29 to 34 weeks
Conditions the study is for: Infant, Newborn, Infant, Moderate Preterm
What is being tested?: Weaning from an incubator at a lower weight (1600 grams) and Weaning from an incubator at a higher weight (1800 grams)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 366 participants
Where: 18 sitesUnited States
Study dates: Feb 2015to Jun 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 29 to 34 weeks
All sexes
No healthy volunteers
Child

Who may be able to join

Gestational age 29 0/7 to 33 6/7 weeks at birth
Birth weight less than 1600 grams
Greater than 48 hours of age
Current weight less than 1540 grams
In an incubator

Who cannot join

Receiving phototherapy
Receiving respiratory support (including CPAP, ventilation, HFNC > 2 LPM)
Receiving blood pressure support
Designated for transfer to referral hospital while in incubator
Known major congenital or chromosomal anomaly

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

University of New Mexico
Albuquerque, New Mexico, 87131
Emory University
Atlanta, Georgia, 30303
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267
Case Western Reserve University
Cleveland, Ohio, 44106
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Wayne State University
Detroit, Michigan, 48201
RTI International
Durham, North Carolina, 27705
Duke University
Durham, North Carolina, 27710
Indiana University
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
Children's Mercy Hospital
Kansas City, Missouri, 64108
University of California - Los Angeles
Los Angeles, California, 90025
Stanford University
Palo Alto, California, 94304
Univeristy of Pennsylvania
Philadelphia, Pennsylvania, 19104
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
University of Rochester
Rochester, New York, 14642

Other trials in United States

About this study

Official title: Incubator Weaning of Moderately Preterm Infants: A Randomized Controlled Trial

The hypothesis of this study is that length of hospital stay (from birth to discharge) will be decreased among moderate preterm infants weaned from an incubator to an open crib at a lower versus higher weight, 1600g vs. 1800g.

Conditions: Infant, Newborn, Infant, Moderate Preterm
Being tested: Weaning from an incubator at a lower weight (1600 grams), Weaning from an incubator at a higher weight (1800 grams)
Keywords: Incubator Weaning, Moderately Preterm Infants, Growth Velocity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Weaning from an incubator at a lower weight (1600 grams)Procedure or surgery
Infants will be weaned from an incubator at a lower weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)Procedure or surgery
Infants will be weaned from an incubator at a higher weight (1800 grams)

Study groups in NCT02160002
Study group	Role	What they receive
Lower Weight (1600 grams)	Active comparator	Weaning from an incubator at a lower weight (1600 grams) Receives: Procedure: Weaning from an incubator at a lower weight (1600 grams)
Higher Weight (1800 grams)	Active comparator	Weaning from an incubator at a higher weight (1800 grams) Receives: Procedure: Weaning from an incubator at a higher weight (1800 grams)

What is being measured

The primary outcome is the main question the study is designed to answer.

Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)
Number of days the infant stays in hospital after birth until discharge home (up to 120 days).
Measured: From birth through discharge

Secondary outcomes (11)

Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days)
Among infants who were successfully weaned, the number of days in the hospital counting from the start of weaning from the incubator to the crib through discharge from the hospital (up to 120 days).
Measured: From start of weaning from the incubator to crib through discharge (up to 120 days)
Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts)
Failure of wean is defined as axillary temperature less than 36.3°C after one hour in the crib on 2 successive readings, 3 to 4 hours apart, within 24 hours of weaning to the crib in spite of additional clothes/coverings.
Measured: Through completion of 2 weaning attempts
Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA)
Growth velocity in terms of weight (g/kg/day), considering infant weight at start of weaning from incubator to crib (following random assignment) and weight at 36 weeks postmenstrual age (PMA).
Measured: Start of weaning from incubator through 36 weeks postmenstrual age (PMA)
Growth Parameters: Weight at Status
Infant weight at status is measured at the time of discharge, death, transfer to another facility, or 120 days.
Measured: Status (discharge, death, transfer to another facility, or 120 days)
Growth Parameters: Length at Status
Infant length at status is measured at the time of discharge, death, transfer to another facility, or 120 days.
Measured: Status (discharge, death, transfer to another facility, or 120 days)
Growth Parameters: Head Circumference at Status
Infant head circumference at status is measured at the time of discharge, death, transfer to another facility, or 120 days.
Measured: Status (discharge, death, transfer to another facility, or 120 days)
Postmenstrual Age (PMA) at Discharge
Postmenstrual age (PMA) at discharge is the sum of the gestational age of the infant and its length of stay in hospital from birth to discharge.
Measured: Discharge
Readmission to the Hospital Within 1 Week of Discharge
Number of infants re-hospitalized within 1 week (7 days) of discharge.
Measured: Discharge through 1 week after discharge.
Death Among Enrolled Infants
Measured: Status (discharge, death, transfer to another facility, or 120 days)
Transferred to a Non-Network Hospital
Number of infants transferred to another non-Network hospital.
Measured: Status (discharge, death, transfer to another facility, or 120 days)
Length of Stay (LOS) Following Randomization to Hospital Discharge
The number of days the infant stayed in hospital after randomization to the study until discharge.
Measured: From randomization through discharge.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Jun 2017

First posted10 Jun 2014 (estimated)
Study startFeb 2015
Primary completionJul 2016
Study completionJun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Infant, 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 366 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02160002
Sponsor's protocol ID: NICHD-NRN-0054
Status last verified: Mar 2019
First submitted: 8 May 2014
Last updated: 22 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Chowdhary V, Shukla A. Weaning of moderately preterm infants from the incubator to the crib: a randomized clinical trial. Acta Paediatr. 2019 Jul;108(7):1364. doi: 10.1111/apa.14774. Epub 2019 Apr 29. No abstract available.
PubMed 31033050
Shankaran 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Incubator Weaning of Moderately Preterm Infants: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02160002
Acronym / sponsor ID: NICHD-NRN-0054
Conditions: Infant, Newborn, Infant, Moderate Preterm
Keywords: Incubator Weaning, Moderately Preterm Infants, Growth Velocity
Study type: Interventional
Recruitment status: Completed
Enrolment: 366 participants (actual)
Lead sponsor: NICHD Neonatal Research NetworkResearch network
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Feb 2015 (actual)
Primary completion: Jul 2016 (actual)
Study completion: Jun 2017 (actual)
First posted: 10 Jun 2014 (estimated)
Results: Posted 21 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Lower Weight (1600 grams)	Active comparator	Procedure: Weaning from an incubator at a lower weight (1600 grams)Weaning from an incubator at a lower weight (1600 grams)
Higher Weight (1800 grams)	Active comparator	Procedure: Weaning from an incubator at a higher weight (1800 grams)Weaning from an incubator at a higher weight (1800 grams)

Who may qualify

Ages: 29 to 34 weeks
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Gestational age 29 0/7 to 33 6/7 weeks at birth
Birth weight less than 1600 grams
Greater than 48 hours of age
Current weight less than 1540 grams
In an incubator

Key exclusion criteria (5 listed)

Receiving phototherapy
Receiving respiratory support (including CPAP, ventilation, HFNC > 2 LPM)
Receiving blood pressure support
Designated for transfer to referral hospital while in incubator
Known major congenital or chromosomal anomaly

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 an incubator at a lower weight (1600 grams)Infants will be weaned from an incubator at a lower weight (1600 grams)	Procedure or surgery	Lower Weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)Infants will be weaned from an incubator at a higher weight (1800 grams)	Procedure or surgery	Higher Weight (1800 grams)

Primary outcome

Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)
Time frame: From birth through discharge
Number of days the infant stays in hospital after birth until discharge home (up to 120 days).

11 secondary outcomes

Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days)
Time frame: From start of weaning from the incubator to crib through discharge (up to 120 days)
Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts)
Time frame: Through completion of 2 weaning attempts
Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA)
Time frame: Start of weaning from incubator through 36 weeks postmenstrual age (PMA)
Growth Parameters: Weight at Status
Time frame: Status (discharge, death, transfer to another facility, or 120 days)
Growth Parameters: Length at Status
Time frame: Status (discharge, death, transfer to another facility, or 120 days)
Growth Parameters: Head Circumference at Status
Time frame: Status (discharge, death, transfer to another facility, or 120 days)
Postmenstrual Age (PMA) at Discharge
Time frame: Discharge
Readmission to the Hospital Within 1 Week of Discharge
Time frame: Discharge through 1 week after discharge.
Death Among Enrolled Infants
Time frame: Status (discharge, death, transfer to another facility, or 120 days)
Transferred to a Non-Network Hospital
Time frame: Status (discharge, death, transfer to another facility, or 120 days)
Length of Stay (LOS) Following Randomization to Hospital Discharge
Time frame: From randomization through discharge.

Results and safety

Results posted to the registry on 21 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lower Weight (1600 Grams)	187	185
Higher Weight (1800 Grams)	179	178

Primary outcome: Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)

Time frame: From birth through discharge. Median (Inter-Quartile Range). Unit: days

Measure	Lower Weight (1600 Grams) n = 185	Higher Weight (1800 Grams) n = 178
Value	43 (32 to 55)	41 (33 to 52)

Population analysed: 185 infants in the lower weight group and 178 infants in the higher weight group have the date of discharge available.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lower Weight (1600 Grams)	1 of 187 (0.5%)	19 of 187 (10.2%)	0 of 187
Higher Weight (1800 Grams)	0 of 179 (0%)	7 of 179 (3.9%)	0 of 179

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31033050Chowdhary V, Shukla A. Weaning of moderately preterm infants from the incubator to the crib: a randomized clinical trial. Acta Paediatr. 2019 Jul;108(7):1364. doi: 10.1111/apa.14774. Epub 2019 Apr 29. No abstract available.
Derived from this study: 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.
NICHD Neonatal Research Network siteLink provided by the sponsor.
NICHD Pregnancy \& Perinatology BranchLink provided by the sponsor.

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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.

Michele C Walsh, MD principal investigator

Case Western Reserve University, Rainbow Babies and Children's Hospital

Myra Wyckoff, MD principal investigator

University of Texas, Southwestern Medical Center at Dallas

Seetha Shankaran, MD study chair

Wayne State University

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites 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?

Yes. Results are posted in the registry (first posted 21 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days) (time frame: From birth through discharge). 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 NCT02160002, 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 22 Mar 2019.