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

Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721629
• Other study ID #: AAUH190280
• Status: Completed
• Phase: N/A
• First received: September 25, 2012
• Last updated: April 28, 2017
• Start date: September 2012
• Est. completion date: April 28, 2017

Study information

• Verified date: April 2017
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: April 28, 2017
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Prematurity
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Infant
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• Sudden wean of nasal CPAP

• Gradual wean of nasal CPAP

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital, Department of Pediatrics	Aalborg	DK
Denmark	Aarhus University Hospital, Department of Pediatrics	Aarhus	DK
Denmark	Herning Hospital, Department of Pediatrics	Herning	DK
Denmark	Vendsyssel Hospital, Department of Pediatrics	Hjørring
Denmark	Randers Hospital, Department of Pediatrics	Randers
Denmark	Viborg Hospital, Department of Pediatrics	Viborg	DK

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight at a gestational age of 40 weeks		Up to 16 weeks
Secondary	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
Secondary	Duration of oxygen treatment		Up to 6 months
Secondary	Duration of nasal CPAP therapy		Up to 6 months
Secondary	Length of stay in the hospital		Expected median 54 days
Secondary	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
Secondary	Parental anxiety		Up to 6 months
Secondary	Depression in parents		Up to 6 months