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Completed

NCT Number: NCT00188968

Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants.

Very premature infants uniformly do not have mature functioning lungs to breathe well nor mature regulation mechanisms to breathe regularly. Assistance with a mechanical respirator is common. However, prolonged use of a respirator can itself cause long-term complications. Furthermore, commonly used drugs to improve the regularity of breathing may have long-term consequence only recently recognized. This study will compare two different types of assistance using a nasally applied breathing assist device. The aim is to see which type of assistance is best at avoiding the need for both prolonged respirator use and drugs to regulate breathing.

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Key information

Conditions

Apnea Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases Ventilator-Induced Lung Injury

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Health Sciences Centre, Winnipeg, Manitoba, Canada

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About this study

Early extubation of premature infants may limit the deleterious effects of positive pressure ventilation. The primary cause of failure of extubation (and the need for reintubation) is apnea of prematurity. Standard treatment for improving extubation success and decreasing apnea of prematurity is with the use of nasal continuous positive airway pressure (nCPAP), use of methylxanthines, or both. Recent literature suggests that methylxanthines may have significant effect on long-term neurodevelopmental outcome.

This primary objective of this study is to investigate the effect of synchronized nasal intermittent positive pressure ventilation (sNIPPV) combined with standard nasal continuous positive airway pressure (nCPAP) versus standard nCPAP alone, on the need for reintubation and the need of methylxanthine therapy in premature infants. The study period for the primary objective will be the first 7 days immediately after the initial extubation of premature infants with birth weights 500-1250 grams. A secondary objective is to identify any differences in duration of time free of endotracheal intubation and duration of time free of methylxanthine use between the two treatment modalities as measured from the first extubation attempt.

The study is a randomized, controlled trial using a new CPAP machine (Infant Flow advance™) that will be able to provide nCPAP with and without sNIPPV. Because of the mechanics of the sNIPPV mode, blinding of the study is not possible. The study is pragmatic in design allowing the medical staff to make clinical decisions on ventilatory management based on the routinely used criteria thus evaluating the study interventions in the everyday clinical environment. Analysis will be on an intention-to-treat basis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Premature infants with birth weight 500-1250 grams
  • first attempt at extubation

Exclusion criteria

(clinical suspicion or documented diagnosis of:

  • neuromuscular disease
  • chromosomal abnormality
  • or any congenital anomalies that would affect ability to be extubated from mechanical ventilation via endotracheal tube (i.e. congenital cardiac anomalies, choanal atresia).

Treatment and study plan

nasal continuous positive airway pressure

Procedure

Synchronized Nasal Positive Pressure Ventilation

Procedure

Primary outcomes

  1. Need for methylxanthine treatment OR the need for re-intubation in the first 7 days after the initial extubation in preterm infants intubated for treatment of respiratory distress.

    Time frame: 7 days immediately after first extubation attempt

Secondary outcomes

  1. Duration of time to methylxanthine treatment.

    Time frame: During first 7 days and during hospitalization

  2. Duration of supplemental oxygen use

    Time frame: During hospitalization

  3. Incidence of bronchopulmonary dysplasia (both 28 days of age, and 36 weeks PCA)

    Time frame: 28 days of age, 36 weeks PCA

  4. Frequency of apneas during the initial 7 days post-extubation.

    Time frame: Initial 7 days post-extubation

  5. Complications of therapy (air leak syndromes, gastric and intestinal distension).

    Time frame: During Hospitalization

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Health Sciences Centre Foundation, Manitoba

Registry information

Official study title

A Randomized, Controlled Trial of Synchronized Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Airway Pressure Using the Infant Flow Advance to Facilitate Successful Extubation in Premature Infants.

Important dates

Study start
2004
Study completion
2007
First posted
Sep 16, 2005
Registry last updated
May 2, 2007

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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