Respiratory Distress SyndromeNCT02126501
Comparing Weaning of Nasal Continuous Positive Airway Pressure (CPAP) From Preterm Infants
A study testing Gradual pressure wean in people with Respiratory Distress Syndrome, run by Maimonides Medical Center at 1 site in United States.
Trial summary
To compare the 2 methods of weaning of nasal continuous positive airway pressure (CPAP) in premature babies born between 26 and 32 weeks Read more about this study
- Who is it for?
- Ages 26 to 32 weeks
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Gradual pressure wean
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2015
- 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 26 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All neonates born 26 to 32 weeks of gestational age
Who cannot join
- Those with severe congenital anomalies and chromosomal defects including congenital heart disease, neurological malformations, chest and airway abnormalities and lung hypoplasia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial of Weaning NCPAP From Preterm Infants: Sudden Wean Versus Weaning by Gradually Decreasing Pressure
To compare the 2 methods of weaning of nasal continuous positive airway pressure (CPAP) in premature babies born between 26 and 32 weeks
Read the detailed description
To study the weight and the post menstrual age (PMA) at the time of NCPAP wean utilizing the method of sudden wean as compared to gradual wean.
Methods: A prospective randomized trial was conducted comparing sudden weaning with gradual weaning from NCPAP in neonates with gestational age between 26 and 32 weeks. The patients were randomized to one of the two methods of weaning from NCPAP and their success was compared
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Gradual pressure wean
- Keywords
- weaning, NCPAP, Preterm, sudden wean, gradual pressure off wean
- Medical subject headings
- Respiratory Distress Syndrome, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gradual pressure weanOther
NCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided
| Study group | Role | What they receive |
|---|---|---|
| Sudden wean | No intervention | When ready Nasal Continuous Positive Airway Pressure (NCPAP) will be removed from the neonate |
| Gradual pressure wean | Active comparator | NCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided Receives: Other: Gradual pressure wean |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of weaning on first trial off NCPAP
Measured: Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks
Secondary outcomes (2)
Weight and corrected GA when come off oxygen
Measured: when off supplemental oxygen expected average of 2 weeks
Weight and corrected gestational age (GA) when neonates could come off NCPAP
Measured: Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shantanu Rastogi, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126501
- Sponsor's protocol ID
- MMC 13/01/VA03
- Status last verified
- Jun 2016
- First submitted
- 17 Mar 2014
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Amatya S, Macomber M, Bhutada A, Rastogi D, Rastogi S. Sudden versus gradual pressure wean from Nasal CPAP in preterm infants: a randomized controlled trial. J Perinatol. 2017 Jun;37(6):662-667. doi: 10.1038/jp.2017.10. Epub 2017 Feb 23.
PubMed 28230835
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Weaning NCPAP From Preterm Infants: Sudden Wean Versus Weaning by Gradually Decreasing Pressure
- ClinicalTrials.gov ID
- NCT02126501
- Acronym / sponsor ID
- MMC 13/01/VA03
- Conditions
- Respiratory Distress Syndrome
- Keywords
- weaning, NCPAP, Preterm, sudden wean, gradual pressure off wean
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Apr 2014 (estimated)
- 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.
To compare the 2 methods of weaning of nasal continuous positive airway pressure (CPAP) in premature babies born between 26 and 32 weeks
Detailed description
To study the weight and the post menstrual age (PMA) at the time of NCPAP wean utilizing the method of sudden wean as compared to gradual wean.
Methods: A prospective randomized trial was conducted comparing sudden weaning with gradual weaning from NCPAP in neonates with gestational age between 26 and 32 weeks. The patients were randomized to one of the two methods of weaning from NCPAP and their success was compared
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sudden wean | No intervention | –When ready Nasal Continuous Positive Airway Pressure (NCPAP) will be removed from the neonate |
| Gradual pressure wean | Active comparator | Other: Gradual pressure weanNCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided |
Who may qualify
- Ages
- 26 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All neonates born 26 to 32 weeks of gestational age
Key exclusion criteria (1 listed)
- Those with severe congenital anomalies and chromosomal defects including congenital heart disease, neurological malformations, chest and airway abnormalities and lung hypoplasia
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 |
|---|---|---|
| Gradual pressure weanNCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided | Other | Gradual pressure wean |
Primary outcome
Success of weaning on first trial off NCPAP
Time frame: Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks
2 secondary outcomes
Weight and corrected GA when come off oxygen
Time frame: when off supplemental oxygen expected average of 2 weeks
Weight and corrected gestational age (GA) when neonates could come off NCPAP
Time frame: Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
- Derived from this study: PubMed 28230835Amatya S, Macomber M, Bhutada A, Rastogi D, Rastogi S. Sudden versus gradual pressure wean from Nasal CPAP in preterm infants: a randomized controlled trial. J Perinatol. 2017 Jun;37(6):662-667. doi: 10.1038/jp.2017.10. Epub 2017 Feb 23.
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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.
Shantanu Rastogi, MD principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gradual pressure wean in people with Respiratory Distress Syndrome, run by Maimonides Medical Center 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 1 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 8 Jun 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Success of weaning on first trial off NCPAP (time frame: Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 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 NCT02126501, which also lists 1 linked publication.
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 8 Jun 2016.