Preterm NeonatesNCT01215591
Trial of Weaning of Nasal Continuous Positive Airway Pressure (CPAP)
A study testing Gradual weaning from Nasal CPAP in preterm neonates in people with Preterm Neonates, run by Maimonides Medical Center at 1 site in United States.
Trial summary
To compare the 2 methods of weaning of nasal CPAP in premature babies born at 32 weeks or less Read more about this study
- Who is it for?
- Ages 24 to 32 weeks
- Conditions the study is for
- Preterm Neonates
- What is being tested?
- Gradual weaning from Nasal CPAP in preterm neonates
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Mar 2009
- 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 24 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All babies born with GA <32 weeks admitted to the neonatal intensive care units at the Maimonides Infant and Children's Hospital, between 1st January 2008 and 31st March 2009 and required to be on NCPAP for longer than 48 hours.-
Who cannot join
- Those with severe congenital anomalies and chromosomal defects including congenital heart disease and neurological malformations, chest wall or airway abnormalities and lung hypoplasia, were excluded from the cohort
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Gradual Versus Sudden Weaning From Nasal CPAP in Preterm Neonates
To compare the 2 methods of weaning of nasal CPAP in premature babies born at 32 weeks or less
Read the detailed description
Objective: To study the weight and the post menstrual age (PMA) at the time of nasal CPAP (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 (GA) <32 weeks. The patients were randomized to one of the two methods of weaning from NCPAP and their success was compared.
- Conditions
- Preterm Neonates
- Being tested
- Gradual weaning from Nasal CPAP in preterm neonates
- Keywords
- Neonatal, Nasal CPAP, Randomized controlled trial, Weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gradual weaning from Nasal CPAP in preterm neonatesProcedure or surgery
Also called Nasal CPAP, Weaning, Preterm neonates
Nasal CPAP for gradual wean group it was cycled off for 3 hours alternating with 3 hours on for first 48 hours, if successful the cycle was extended to 6 hours off and 3 hours on for the next 48 hours. If the baby tolerated this regime the prongs were removed and CPAP was kept off.
| Study group | Role | What they receive |
|---|---|---|
| Gradual wean from Nasal CPAP | Active comparator | Nasal CPAP for gradual wean group it was cycled off for 3 hours alternating with 3 hours on for first 48 hours, if successful the cycle was extended to 6 hours off and 3 hours on for the next 48 hours. If the baby tolerated this regime the prongs were removed and CPAP was kept off. Receives: Procedure: Gradual weaning from Nasal CPAP in preterm neonates |
| Sudden wean from Nasal CPAP | No intervention | Usual practice to wean the preterm neonates from nasal CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight when preterm neonates could come off nasal CPAP
Weight when preterm neonates could come off nasal CPAP
Measured: During the initial NICU stay
Post-menstrual age when preterm neonates could come off nasal CPAP
Post-menstrual age when preterm neonates could come off nasal CPAP
Measured: During the initial NICU stay
Secondary outcomes (3)
Weights when the neonates could come off oxygen
Weights when the neonates could come off oxygen
Measured: During the initial NICU stay
length of stay in the hospital
length of stay in the hospital
Measured: During the initial NICU stay
Post-menstrual age when preterm neonates could come off oxygen
Post-menstrual age when preterm neonates could come off oxygen
Measured: During the initial NICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startJan 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm NeonatesStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shantanu Rastogi, Maimonides Medical Center
- Investigators
- Shantanu Rastogi, MD, Principal investigator, Maimonides Medical CenterAlok Bhutada, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215591
- Sponsor's protocol ID
- Maimonides Project 07/10/VA5
- Status last verified
- Oct 2012
- First submitted
- 27 Sep 2010
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Gradual Versus Sudden Weaning From Nasal CPAP in Preterm Neonates
- ClinicalTrials.gov ID
- NCT01215591
- Acronym / sponsor ID
- Maimonides Project 07/10/VA5
- Conditions
- Preterm Neonates
- Keywords
- Neonatal, Nasal CPAP, Randomized controlled trial, Weaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Oct 2010 (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 CPAP in premature babies born at 32 weeks or less
Detailed description
Objective: To study the weight and the post menstrual age (PMA) at the time of nasal CPAP (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 (GA) <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 |
|---|---|---|
| Gradual wean from Nasal CPAP | Active comparator | Procedure: Gradual weaning from Nasal CPAP in preterm neonatesNasal CPAP for gradual wean group it was cycled off for 3 hours alternating with 3 hours on for first 48 hours, if successful the cycle was extended to 6 hours off and 3 hours on for the next 48 hours. If the baby tolerated this regime the prongs were removed and CPAP was kept off. |
| Sudden wean from Nasal CPAP | No intervention | –Usual practice to wean the preterm neonates from nasal CPAP |
Who may qualify
- Ages
- 24 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All babies born with GA <32 weeks admitted to the neonatal intensive care units at the Maimonides Infant and Children's Hospital, between 1st January 2008 and 31st March 2009 and required to be on NCPAP for longer than 48 hours.-
Key exclusion criteria (1 listed)
- Those with severe congenital anomalies and chromosomal defects including congenital heart disease and neurological malformations, chest wall or airway abnormalities and lung hypoplasia, were excluded from the cohort
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 weaning from Nasal CPAP in preterm neonatesAlso: Nasal CPAP, Weaning, Preterm neonatesNasal CPAP for gradual wean group it was cycled off for 3 hours alternating with 3 hours on for first 48 hours, if successful the cycle was extended to 6 hours off and 3 hours on for the next 48 hours. If the baby tolerated this regime the prongs were removed and CPAP was kept off. | Procedure or surgery | Gradual wean from Nasal CPAP |
Primary outcome
Weight when preterm neonates could come off nasal CPAP
Time frame: During the initial NICU stay
Weight when preterm neonates could come off nasal CPAP
Post-menstrual age when preterm neonates could come off nasal CPAP
Time frame: During the initial NICU stay
Post-menstrual age when preterm neonates could come off nasal CPAP
3 secondary outcomes
Weights when the neonates could come off oxygen
Time frame: During the initial NICU stay
length of stay in the hospital
Time frame: During the initial NICU stay
Post-menstrual age when preterm neonates could come off oxygen
Time frame: During the initial NICU stay
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 24 Oct 2012.
- pubmed abstractLink 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.
Shantanu Rastogi, MD principal investigator
Maimonides Medical Center
Alok Bhutada, 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 weaning from Nasal CPAP in preterm neonates in people with Preterm Neonates, 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 24 Oct 2012. 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?
Weight when preterm neonates could come off nasal CPAP (time frame: During the initial NICU stay). The study lists 2 primary outcomes in all. 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 24 Oct 2012.