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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sudden wean of nasal CPAP | Other | 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. |
|
| Gradual wean of nasal CPAP pressure | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sudden wean of nasal CPAP | Procedure |
| ||
| Gradual wean of nasal CPAP |
| Measure | Description | Time Frame |
|---|---|---|
| Weight at a gestational age of 40 weeks | Up to 16 weeks |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina F Jensen, MD | The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital | Principal Investigator |
| Tine B Henriksen, Professor | Department of Paediatrics, Aarhus University Hospital | Study Director |
| Kirsten Wisborg, Centre Director, DMSc | Aarhus University Hospital, Head-Neuro Centre | Study Chair |
| Finn Ebbesen, Professor | Department of Paediatrics, Aalborg University Hospital | Study Chair |
| Anna S Sørensen, MD, Ph.D. | The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital, Department of Pediatrics | Aalborg | DK | 9000 | Denmark | ||
| Aarhus University Hospital, Department of Pediatrics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30039171 | Derived | Jensen CF, Sellmer A, Ebbesen F, Cipliene R, Johansen A, Hansen RM, Nielsen JP, Nikitina OH, Petersen JP, Henriksen TB. Sudden vs Pressure Wean From Nasal Continuous Positive Airway Pressure in Infants Born Before 32 Weeks of Gestation: A Randomized Clinical Trial. JAMA Pediatr. 2018 Sep 1;172(9):824-831. doi: 10.1001/jamapediatrics.2018.2074. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D012127 | Respiratory Distress Syndrome, Newborn |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Procedure |
|
| 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 |
| Aarhus |
| DK |
| 8200 |
| Denmark |
| Herning Hospital, Department of Pediatrics | Herning | DK | 7400 | Denmark |
| Viborg Hospital, Department of Pediatrics | Viborg | DK | 8800 | Denmark |
| Vendsyssel Hospital, Department of Pediatrics | Hjørring | 9800 | Denmark |
| Randers Hospital, Department of Pediatrics | Randers | 8930 | Denmark |
| D000091642 | Urogenital Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |