Skip to main content
OpenTrials
Completed

NCT Number: NCT01093495

Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure

There is little data published concerning the best approach to nasal continuous positive airway pressure (nCPAP) weaning. Potential complications associated with prolonged nCPAP therapy include gastric distension, nasal trauma,pneumothorax,agitation and nosocomial infection. Moreover, Infants on nCPAP may also require more intensive nursing care and the use of extra equipment. Therefore, minimizing the amount of time that a patient requires CPAP may be beneficial. On the other hand, removing CPAP too early may lead to complications that include: increasing apnea, increased oxygen requirement, increased work of breathing, the need to re-start CPAP, and intubation and mechanical ventilation. Moreover, an experimental study have demonstrated an improvement in lung growth after the prolonged use of CPAP.

Nasal cannula (NC) flows at 1-2 L/min may also generate a positive pressure in the airway of preterm infants. The use of NC flow to generate positive airway pressure would minimize many of the application issues of nCPAP. However, NC systems used in neonates routinely employ gas that is inadequately warmed and humidified, limiting the use of such flows due to increased risk of nasal mucosa injury, and possibly increasing the risk for nosocomial infection.

The purpose of this randomized controlled trial is to evaluate the clinical impact of two methods for weaning preterm infants from nCPAP.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

28 week–36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Children's Hospital

Al Mansurah, Egypt

About this study

The objective of this study is to test the null hypothesis that in preterm infants with gestational age of 28 to 36 weeks who are stable on CPAP pressure of 5 cmH2O and with oxygen concentrations (FiO2) <0.30, keeping these infants on CPAP or changing them to NC flow of 1-2 L/min will not make any difference in length of hospitalization, length of respiratory support and incidence of complications.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infants born greater than or equal to 28 weeks (28+0) and less than 37 weeks (36+6) gestation
  • CPAP pressure of 5 cm H2O
  • FiO2 requirement = or <0.30
  • Clinically stable on these CPAP parameters for 24 hours pre-randomization:
  • Respiratory rate less than 60
  • No significant chest recession
  • No apnea requiring bagging and/or
  • Not more than 6 apneas requiring stimulation in the preceding 24 h.
  • Average saturation > or = 87%
  • Satisfactory ABG (pH> 7.25, PCO2 < 60, and Base deficit < -8)

Exclusion criteria

  • Life threatening congenital anomalies
  • Congenital cyanotic heart diseases
  • Congenital airway or chest wall abnormalities
  • Pulmonary hypoplasia
  • Known or suspected to have a neuromuscular disorder
  • Congenital neurological disorder, severe IVH (grade 3 or 4), PVL and hydrocephalus

Treatment and study plan

CPAP

Device

CPAP

Nasal Cannula

Device

Nasal Cannula

Primary outcomes

  1. Duration of oxygen use

    Time frame: 3 months

    The number of days for oxygen use from the start of randomization until hospital discharge will be recorded.

Secondary outcomes

  1. Length of respiratory support

    Time frame: 3 months

    The number of days in which the subject requires any sort of respiratory support will be recorded, including: CPAP, nasal cannula and mechanical ventilation.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

A Randomized Controlled Trial on Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Mar 25, 2010
Registry last updated
Mar 25, 2010

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.