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Respiratory Distress SyndromeNCT01093495

Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure

A study testing CPAP and Nasal Cannula in people with Respiratory Distress Syndrome and Hyaline Membrane Disease, run by Mansoura University at 1 site in Egypt.

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

There is little data published concerning the best approach to nasal continuous positive airway pressure (nCPAP) weaning. Potential complications associated with prolonged nCPAP therapy include gastric distension, nasal trauma,pneumothorax,agitation and nosocomial infection. Read more about this study

Who is it for?
Ages 28 to 36 weeks
What is being tested?
CPAP and Nasal Cannula
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
Jan 2009to Jan 2010
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 28 to 36 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Infants born greater than or equal to 28 weeks (28+0) and less than 37 weeks (36+6) gestation
  • CPAP pressure of 5 cm H2O
  • FiO2 requirement = or <0.30
  • Clinically stable on these CPAP parameters for 24 hours pre-randomization:
  • Respiratory rate less than 60
  • No significant chest recession
Show all 10Show fewer
  • No apnea requiring bagging and/or
  • Not more than 6 apneas requiring stimulation in the preceding 24 h.
  • Average saturation > or = 87%
  • Satisfactory ABG (pH> 7.25, PCO2 < 60, and Base deficit < -8)

Who cannot join

  • Life threatening congenital anomalies
  • Congenital cyanotic heart diseases
  • Congenital airway or chest wall abnormalities
  • Pulmonary hypoplasia
  • Known or suspected to have a neuromuscular disorder
  • Congenital neurological disorder, severe IVH (grade 3 or 4), PVL and hydrocephalus

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Mansoura University Children's Hospital

    Al Mansurah

Other trials in Egypt

About this study

Official title: A Randomized Controlled Trial on Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure

There is little data published concerning the best approach to nasal continuous positive airway pressure (nCPAP) weaning. Potential complications associated with prolonged nCPAP therapy include gastric distension, nasal trauma,pneumothorax,agitation and nosocomial infection. Moreover, Infants on nCPAP may also require more intensive nursing care and the use of extra equipment. Therefore, minimizing the amount of time that a patient requires CPAP may be beneficial. On the other hand, removing CPAP too early may lead to complications that include: increasing apnea, increased oxygen requirement, increased work of breathing, the need to re-start CPAP, and intubation and mechanical ventilation. Moreover, an experimental study have demonstrated an improvement in lung growth after the prolonged use of CPAP.

Nasal cannula (NC) flows at 1-2 L/min may also generate a positive pressure in the airway of preterm infants. The use of NC flow to generate positive airway pressure would minimize many of the application issues of nCPAP. However, NC systems used in neonates routinely employ gas that is inadequately warmed and humidified, limiting the use of such flows due to increased risk of nasal mucosa injury, and possibly increasing the risk for nosocomial infection.

The purpose of this randomized controlled trial is to evaluate the clinical impact of two methods for weaning preterm infants from nCPAP.

Read the detailed description

The objective of this study is to test the null hypothesis that in preterm infants with gestational age of 28 to 36 weeks who are stable on CPAP pressure of 5 cmH2O and with oxygen concentrations (FiO2) <0.30, keeping these infants on CPAP or changing them to NC flow of 1-2 L/min will not make any difference in length of hospitalization, length of respiratory support and incidence of complications.

Being tested
CPAP, Nasal Cannula
Keywords
Nasal Continuous positive Airway pressure, Nasal Cannula, CPAP, Premature, RDS, HMD, NICU
Medical subject headings
Respiratory Distress Syndrome, Hyaline Membrane Disease, Premature Birth

What participants receive

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

  • CPAPDevice

    CPAP

  • Nasal CannulaDevice

    Nasal Cannula

Study groups in NCT01093495
Study groupRoleWhat they receive
CPAP groupExperimentalSubjects in this group will continue receiving CPAP until no oxygen requirement for 24 hours, then will be weaned off CPAP completely as long as they tolerate. CPAP will be re-instituted if subjects meet failing criteria. Another trial off CPAP will start 24 hours after failure and/or after being on 21% for 24 hours. CPAP will be weaned off directly to room air at all times.
Receives: Device: CPAP
Nasal Cannula GroupExperimentalSubjects will be weaned from CPAP (when FiO2 <0.30) to Nasal cannula (2 L/min) with whatever FiO2 they need until they are off oxygen and NC completely. However, if these infants fail on NC they will be put back to nCPAP. Infants will then be maintained on CPAP until stable on CPAP-30% for 24 hours. Infants will be tried for another weaning using NC. So, infants assigned to NC will be weaned only through NC. CPAP will be used only for stabilization in between trials if needed.
Receives: Device: Nasal Cannula

What is being measured

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

  1. Duration of oxygen use

    The number of days for oxygen use from the start of randomization until hospital discharge will be recorded.

    Measured: 3 months

Secondary outcomes (1)

  1. Length of respiratory support

    The number of days in which the subject requires any sort of respiratory support will be recorded, including: CPAP, nasal cannula and mechanical ventilation.

    Measured: 3 months

Timeline

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

  1. First posted25 Mar 2010 (estimated)
  2. Study startJan 2009
  3. Primary completionDec 2009
  4. Study completionJan 2010

Resources

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01093495
Sponsor's protocol ID
20081230
Status last verified
Mar 2010
First submitted
24 Mar 2010
Last updated
25 Mar 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Ho JJ, Henderson-Smart DJ, Davis PG. Early versus delayed initiation of continuous distending pressure for respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev. 2002;2002(2):CD002975. doi: 10.1002/14651858.CD002975.

    PubMed 12076463

  • Ho JJ, Subramaniam P, Henderson-Smart DJ, Davis PG. Continuous distending pressure for respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev. 2002;(2):CD002271. doi: 10.1002/14651858.CD002271.

    PubMed 12076445

  • Aly H, Massaro AN, Patel K, El-Mohandes AA. Is it safer to intubate premature infants in the delivery room? Pediatrics. 2005 Jun;115(6):1660-5. doi: 10.1542/peds.2004-2493.

    PubMed 15930230

  • Aly H, Massaro AN, Hammad TA, Narang S, Essers J. Early nasal continuous positive airway pressure and necrotizing enterocolitis in preterm infants. Pediatrics. 2009 Jul;124(1):205-10. doi: 10.1542/peds.2008-2588.

    PubMed 19564301

  • Abdel-Hady H, Matter M, Hammad A, El-Refaay A, Aly H. Hemodynamic changes during weaning from nasal continuous positive airway pressure. Pediatrics. 2008 Nov;122(5):e1086-90. doi: 10.1542/peds.2008-1193.

    PubMed 18977958

  • Aly H. Is there a strategy for preventing bronchopulmonary dysplasia? Absence of evidence is not evidence of absence. Pediatrics. 2007 Apr;119(4):818-20. doi: 10.1542/peds.2006-3026. No abstract available.

    PubMed 17403854

  • Aly H, Massaro AN, El-Mohandes AA. Can delivery room management impact the length of hospital stay in premature infants? J Perinatol. 2006 Oct;26(10):593-6. doi: 10.1038/sj.jp.7211575. Epub 2006 Jul 20.

    PubMed 16855619

  • Aly H, Milner JD, Patel K, El-Mohandes AA. Does the experience with the use of nasal continuous positive airway pressure improve over time in extremely low birth weight infants? Pediatrics. 2004 Sep;114(3):697-702. doi: 10.1542/peds.2003-0572-L.

    PubMed 15342841

  • Abdel-Hady H, Shouman B, Aly H. Early weaning from CPAP to high flow nasal cannula in preterm infants is associated with prolonged oxygen requirement: a randomized controlled trial. Early Hum Dev. 2011 Mar;87(3):205-8. doi: 10.1016/j.earlhumdev.2010.12.010. Epub 2011 Jan 26.

    PubMed 21276671

Questions about this trial

What is this clinical trial studying?

A study testing CPAP and Nasal Cannula in people with Respiratory Distress Syndrome and Hyaline Membrane Disease, run by Mansoura University at 1 site in Egypt.

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 10 inclusion and 6 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 25 Mar 2010. 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 Egypt. 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?

Duration of oxygen use (time frame: 3 months). 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 NCT01093495, which also lists 9 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 25 Mar 2010.

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