Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure

Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093495
• Other study ID #: 20081230
• Status: Completed
• Phase: N/A
• First received: March 24, 2010
• Last updated: March 24, 2010
• Start date: January 2009
• Est. completion date: January 2010

Study information

• Verified date: March 2010
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Minstery of Health and Population
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Weeks to 36 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Premature Birth
• Premature Infants
• Preterm Infants
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• CPAP
CPAP
• Nasal Cannula
Nasal Cannula

Locations

Country	Name	City	State
Egypt	Mansoura University Children's Hospital	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

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. Erratum in: Pediatrics. 2009 Aug;124(2):847. — View 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. Epub 2006 Jul 20. — View 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. — View 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. — View 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. — View 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. Review. — View 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;(2):CD002975. Review. — View 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. Review. Update in: Cochrane Database Syst Rev. 2015;7:CD002271. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of oxygen use	The number of days for oxygen use from the start of randomization until hospital discharge will be recorded.	3 months	No
Secondary	Length of respiratory support	The number of days in which the subject requires any sort of respiratory support will be recorded, including: CPAP, nasal cannula and mechanical ventilation.	3 months	No