Respiratory Distress Syndrome, NewbornNCT07009366
Comparison of Methods of Weaning From Nasal CPAP in Preterm Infants: A Randomized Controlled Trial
A study testing Sudden weaning of NCPAP, Gradual weaning with increasing the time off NCPAP and Pressure weaning of NCPAP in people with Respiratory Distress Syndrome, Newborn, run by RESnTEC, Institute of Research at 1 site in Pakistan.
Trial summary
This study aimed to determine the efficacy of different NCPAP weaning strategies in pre-term infants presenting with respiratory distress, and ultimately establishing the best method to withdraw from NCPAP. Read more about this study
- Who is it for?
- Ages 1 hour to 24 hours
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- What is being tested?
- Sudden weaning of NCPAP, Gradual weaning with increasing the time off NCPAP and Pressure weaning of NCPAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2024to 31 Dec 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 1 hour to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants
- Any gender
- Low birth weight
- Gestational ages between 28 to below 37 weeks
- Presented with respiratory distress
- Neonates with radiological findings suggestive of respiratory distress, congenital pneumonia/sepsis, or transient tachypnea of the newborn (TTN)
Who cannot join
- Complex congenital abnormalities like diaphragmatic hernia, CNS malformations, intrapartum-related hypoxia, or congenital heart disease.
- Intraventricular hemorrhage grade III or IV or low APGAR scores (<4 or 5 at 5 minutes)
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to determine the efficacy of different NCPAP weaning strategies in pre-term infants presenting with respiratory distress, and ultimately establishing the best method to withdraw from NCPAP.
Read the detailed description
Pakistan, as well as other developing countries, lacks data regarding the weaning protocol of NCPAP. Ascertaining the best weaning method that could facilitate a shorter duration on nasal CPAP and the least length of hospital stay is very much needed. Findings of this study would help clinicians to achieve better outcomes for the patients receiving nasal CPAP.
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- Sudden weaning of NCPAP, Gradual weaning with increasing the time off NCPAP, Pressure weaning of NCPAP
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sudden weaning of NCPAPProcedure or surgery
NCPAP was taken "off" entirely when the neonate met the "stability criteria" and remained on oxygen or room air via a headbox or incubator with an aim to stay off NCPAP.
Gradual weaning with increasing the time off NCPAPProcedure or surgery
The regimen adopted for this method was 1 hour off twice a day on the 1st day, then 2 hours off twice a day on the 2nd day, hence increasing the time off to 6 hours twice a day (or 12 hours per day), i.e., using a smaller period off. At this point, NCPAP was taken off completely.
Pressure weaning of NCPAPProcedure or surgery
In this method the pressure was reduced in steps of 1 cm of H2O every 12 to 24 hours until 5 cm of H2O, and then if the child tolerated it well, NCPAP was removed, and the child was shifted to oxygen via incubator or room air according to the situation.
| Study group | Role | What they receive |
|---|---|---|
| Sudden weaning of NCPAP | Experimental | NCPAP was taken "off" entirely when the neonate met the "stability criteria" and remained on oxygen or room air via a headbox or incubator with an aim to stay off NCPAP. Receives: Procedure: Sudden weaning of NCPAP |
| Gradual Weaning with increasing the time off NCPAP | Experimental | The regimen adopted for this method was 1 hour off twice a day on the 1st day, then 2 hours off twice a day on the 2nd day, hence increasing the time off to 6 hours twice a day (or 12 hours per day), i.e., using a smaller period off. At this point, NCPAP was taken off completely. Receives: Procedure: Gradual weaning with increasing the time off NCPAP |
| Pressure weaning of NCPAP | Experimental | In this method the pressure was reduced in steps of 1 cm of H2O every 12 to 24 hours until 5 cm of H2O, and then if the child tolerated it well, NCPAP was removed, and the child was shifted to oxygen via incubator or room air according to the situation. Receives: Procedure: Pressure weaning of NCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful weaning
Weaning was considered as successful in the absence of pronounced retractions, tachypnea, or episodes of apnea and if there was no requirement for ventilator support after cessation of NCPAP support.
Measured: 4 days
Secondary outcomes (2)
Comparison of total days on NCPAP
Total days on NCPAP for the three weaning strategies were measured from the start of NCPAP to the removal of NCPAP
Measured: 4 days
Hospital stay
Total days of hospital stay were measured from the admission to discharge from the hospital.
Measured: 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Jul 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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 Syndrome, 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- RESnTEC, Institute of Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabia Asif, Principal investigator, Ziauddin University KarachiHeena Rais, FCPS, Study director, Ziauddin University Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009366
- Sponsor's protocol ID
- DRRABIAZUK
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Publications
Asif R, Rais H, Anwar T, Safdar S. Comparison of methods of Weaning from Nasal Continuous Positive Airway Pressure in Preterm Infants: A Randomized Controlled Trial. Pak J Med Sci. 2026 May;42(5):1243-1249. doi: 10.12669/pjms.42.5.15003.
PubMed 42291608
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Methods of Weaning From Nasal CPAP in Preterm Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07009366
- Acronym / sponsor ID
- DRRABIAZUK
- Conditions
- Respiratory Distress Syndrome, Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- RESnTEC, Institute of ResearchUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 Jun 2025 (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.
This study aimed to determine the efficacy of different NCPAP weaning strategies in pre-term infants presenting with respiratory distress, and ultimately establishing the best method to withdraw from NCPAP.
Detailed description
Pakistan, as well as other developing countries, lacks data regarding the weaning protocol of NCPAP. Ascertaining the best weaning method that could facilitate a shorter duration on nasal CPAP and the least length of hospital stay is very much needed. Findings of this study would help clinicians to achieve better outcomes for the patients receiving nasal CPAP.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sudden weaning of NCPAP | Experimental | Procedure: Sudden weaning of NCPAPNCPAP was taken "off" entirely when the neonate met the "stability criteria" and remained on oxygen or room air via a headbox or incubator with an aim to stay off NCPAP. |
| Gradual Weaning with increasing the time off NCPAP | Experimental | Procedure: Gradual weaning with increasing the time off NCPAPThe regimen adopted for this method was 1 hour off twice a day on the 1st day, then 2 hours off twice a day on the 2nd day, hence increasing the time off to 6 hours twice a day (or 12 hours per day), i.e., using a smaller period off. At this point, NCPAP was taken off completely. |
| Pressure weaning of NCPAP | Experimental | Procedure: Pressure weaning of NCPAPIn this method the pressure was reduced in steps of 1 cm of H2O every 12 to 24 hours until 5 cm of H2O, and then if the child tolerated it well, NCPAP was removed, and the child was shifted to oxygen via incubator or room air according to the situation. |
Who may qualify
- Ages
- 1 hour to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Preterm infants
- Any gender
- Low birth weight
- Gestational ages between 28 to below 37 weeks
- Presented with respiratory distress
Key exclusion criteria (2 listed)
- Complex congenital abnormalities like diaphragmatic hernia, CNS malformations, intrapartum-related hypoxia, or congenital heart disease.
- Intraventricular hemorrhage grade III or IV or low APGAR scores (<4 or 5 at 5 minutes)
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 |
|---|---|---|
| Sudden weaning of NCPAPNCPAP was taken "off" entirely when the neonate met the "stability criteria" and remained on oxygen or room air via a headbox or incubator with an aim to stay off NCPAP. | Procedure or surgery | Sudden weaning of NCPAP |
| Gradual weaning with increasing the time off NCPAPThe regimen adopted for this method was 1 hour off twice a day on the 1st day, then 2 hours off twice a day on the 2nd day, hence increasing the time off to 6 hours twice a day (or 12 hours per day), i.e., using a smaller period off. At this point, NCPAP was taken off completely. | Procedure or surgery | Gradual Weaning with increasing the time off NCPAP |
| Pressure weaning of NCPAPIn this method the pressure was reduced in steps of 1 cm of H2O every 12 to 24 hours until 5 cm of H2O, and then if the child tolerated it well, NCPAP was removed, and the child was shifted to oxygen via incubator or room air according to the situation. | Procedure or surgery | Pressure weaning of NCPAP |
Primary outcome
Successful weaning
Time frame: 4 days
Weaning was considered as successful in the absence of pronounced retractions, tachypnea, or episodes of apnea and if there was no requirement for ventilator support after cessation of NCPAP support.
2 secondary outcomes
Comparison of total days on NCPAP
Time frame: 4 days
Hospital stay
Time frame: 25 days
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 6 Jun 2025.
- Derived from this study: PubMed 42291608Asif R, Rais H, Anwar T, Safdar S. Comparison of methods of Weaning from Nasal Continuous Positive Airway Pressure in Preterm Infants: A Randomized Controlled Trial. Pak J Med Sci. 2026 May;42(5):1243-1249. doi: 10.12669/pjms.42.5.15003.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
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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.
Rabia Asif principal investigator
Ziauddin University Karachi
Heena Rais, FCPS study director
Ziauddin University Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sudden weaning of NCPAP, Gradual weaning with increasing the time off NCPAP and Pressure weaning of NCPAP in people with Respiratory Distress Syndrome, Newborn, run by RESnTEC, Institute of Research at 1 site in Pakistan.
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 6 inclusion and 2 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 6 Jun 2025. 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 Pakistan. 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?
Successful weaning (time frame: 4 days). 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 NCT07009366, 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 6 Jun 2025.