Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants

Study Overview
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Brief Summary
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The aim of this study is to investigate two different strategies for the withdrawal of CPAP in preterm infants born before 32 weeks of gestation.

Official Title
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Weaning of Nasal Continuous Positive Airway Pressure in Infants Born With a Gestational Age Under 32 Weeks: a Randomized Controlled Multicenter Trial

Conditions
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Prematurity, Respiratory Distress Syndrome, Infant

Intervention / Treatment
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* Procedure: Sudden wean of nasal CPAP
* Procedure: Gradual wean of nasal CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age < 32 weeks at birth Current gestational age > 28+6 weeks Nasal CPAP for > 24 hours Nasal CPAP pressure < 8 cmH2O Oxygen requirement < 30% and not increasing Respiratory rate < 70 per minute Less than 3 episodes of oxygen saturation < 70% or a heart rate < 70 beat per minute in the preceding 24 hours Tolerates time off CPAP during cares (up to 15 minutes) Exclusion Criteria: Congenital malformations of the heart (except patent ductus arteriosus, atrial septal defect and patent foramen ovale), lung, and gastrointestinal tract Surgical procedures performed on the gastrointestinal tract Known or suspected to have congenital neuromuscular disease Known or suspected syndrome

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sudden wean of nasal CPAP<br>The CPAP is taken off at the morning ward round. If the discontinuation of the CPAP fails according to prespecified failure criteria, CPAP is recommenced and continued for at least 24 hours. Then a new evaluation takes place and if the infant again meets the inclusion criteria another attempt of sudden wean can be undertaken. Infants are considered successfully weaned if they are off CPAP for three days. | Procedure: Sudden wean of nasal CPAP<br> <br> |
| Other: Gradual wean of nasal CPAP pressure<br>The reduction of the CPAP pressure begins at the morning ward round and the pressure is reduced in steps with 1 cmH2O maximum once a day. Each time the pressure is to be reduced the infant needs to be evaluated according to the inclusion criteria and only if these are still met, will the pressure be reduced. When a CPAP pressure at 4 cmH2O is reached the infant is treated with this pressure for 24 hours and then the CPAP is discontinued. Infants are considered successfully weaned if they are off CPAP for three days. | Procedure: Gradual wean of nasal CPAP<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight at a gestational age of 40 weeks |  | Up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight at completed withdrawal of nasal CPAP |  | From date of birth until the date of complete withdrawal of nasal CPAP. Expected median of 14 days | 
| Duration of oxygen treatment |  | Up to 6 months | 
| Duration of nasal CPAP therapy |  | Up to 6 months | 
| Length of stay in the hospital |  | Expected median 54 days | 
| Occurence of bronchopulmonary dysplasia | The occurrence of bronchopulmonary dysplasia is defined as need for oxygen therapy (> 21%) at a gestational age of 36 weeks or treatment with oxygen > 21% for at least 28 days (a day of treatment with oxygen > 21% means that the infant received oxygen > 21% for more than 12 hours that days) | Up to 12 weeks | 
| Parental anxiety |  | Up to 6 months | 
| Depression in parents |  | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal cpap weaning, Premature infants, Respiratory distress syndrome, Randomized controlled trial