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Completed

NCT Number: NCT01721629

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

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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Key information

Conditions

Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Infant Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Urogenital Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Department of Pediatrics, Aalborg, DK, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sudden wean of nasal CPAP

Procedure

Gradual wean of nasal CPAP

Procedure

Primary outcomes

  1. Weight at a gestational age of 40 weeks

    Time frame: Up to 16 weeks

Secondary outcomes

  1. Weight at completed withdrawal of nasal CPAP

    Time frame: From date of birth until the date of complete withdrawal of nasal CPAP. Expected median of 14 days

  2. Duration of oxygen treatment

    Time frame: Up to 6 months

  3. Duration of nasal CPAP therapy

    Time frame: Up to 6 months

  4. Length of stay in the hospital

    Time frame: Expected median 54 days

  5. Occurence of bronchopulmonary dysplasia

    Time frame: Up to 12 weeks

    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)

  6. Parental anxiety

    Time frame: Up to 6 months

  7. Depression in parents

    Time frame: Up to 6 months

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Nov 6, 2012
Registry last updated
May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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