Clinical trial NCT01093495: Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure
Official title: A Randomized Controlled Trial on Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Hyaline Membrane Disease
Preterm Infants
Premature Infants
Keywords: Nasal Continuous positive Airway pressure
Nasal Cannula
CPAP
Premature
RDS
HMD
NICU
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 28
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of oxygen use
timeFrame: 3 months
Secondary outcomes:
measure: Length of respiratory support
timeFrame: 3 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Children's Hospital
Study officials:
affiliation: Mansoura University Children's Hospital
name: Hesham Abdel Hady, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ho JJ, Henderson-Smart DJ, Davis PG. Early versus delayed initiation of continuous distending pressure for respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev. 2002;2002(2):CD002975. doi: 10.1002/14651858.CD002975.
citation: Ho JJ, Subramaniam P, Henderson-Smart DJ, Davis PG. Continuous distending pressure for respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev. 2002;(2):CD002271. doi: 10.1002/14651858.CD002271.
citation: Aly H, Massaro AN, Patel K, El-Mohandes AA. Is it safer to intubate premature infants in the delivery room? Pediatrics. 2005 Jun;115(6):1660-5. doi: 10.1542/peds.2004-2493.
citation: Aly H, Massaro AN, Hammad TA, Narang S, Essers J. Early nasal continuous positive airway pressure and necrotizing enterocolitis in preterm infants. Pediatrics. 2009 Jul;124(1):205-10. doi: 10.1542/peds.2008-2588.
citation: Abdel-Hady H, Matter M, Hammad A, El-Refaay A, Aly H. Hemodynamic changes during weaning from nasal continuous positive airway pressure. Pediatrics. 2008 Nov;122(5):e1086-90. doi: 10.1542/peds.2008-1193.
citation: Aly H. Is there a strategy for preventing bronchopulmonary dysplasia? Absence of evidence is not evidence of absence. Pediatrics. 2007 Apr;119(4):818-20. doi: 10.1542/peds.2006-3026. No abstract available.
citation: Aly H, Massaro AN, El-Mohandes AA. Can delivery room management impact the length of hospital stay in premature infants? J Perinatol. 2006 Oct;26(10):593-6. doi: 10.1038/sj.jp.7211575. Epub 2006 Jul 20.
citation: Aly H, Milner JD, Patel K, El-Mohandes AA. Does the experience with the use of nasal continuous positive airway pressure improve over time in extremely low birth weight infants? Pediatrics. 2004 Sep;114(3):697-702. doi: 10.1542/peds.2003-0572-L.
citation: Abdel-Hady H, Shouman B, Aly H. Early weaning from CPAP to high flow nasal cannula in preterm infants is associated with prolonged oxygen requirement: a randomized controlled trial. Early Hum Dev. 2011 Mar;87(3):205-8. doi: 10.1016/j.earlhumdev.2010.12.010. Epub 2011 Jan 26.