Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure

NCT ID: NCT01093495

Last Updated: 2010-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-01-31

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.

Conditions

Respiratory Distress Syndrome; Hyaline Membrane Disease; Preterm Infants; Premature Infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPAP group

Subjects in this group will continue receiving CPAP until no oxygen requirement for 24 hours, then will be weaned off CPAP completely as long as they tolerate. CPAP will be re-instituted if subjects meet failing criteria. Another trial off CPAP will start 24 hours after failure and/or after being on 21% for 24 hours. CPAP will be weaned off directly to room air at all times.

Group Type: EXPERIMENTAL

CPAP

Intervention Type: DEVICE

CPAP

Nasal Cannula Group

Subjects will be weaned from CPAP (when FiO2 \<0.30) to Nasal cannula (2 L/min) with whatever FiO2 they need until they are off oxygen and NC completely. However, if these infants fail on NC they will be put back to nCPAP. Infants will then be maintained on CPAP until stable on CPAP-30% for 24 hours. Infants will be tried for another weaning using NC. So, infants assigned to NC will be weaned only through NC. CPAP will be used only for stabilization in between trials if needed.

Group Type: EXPERIMENTAL

Nasal Cannula

Intervention Type: DEVICE

Nasal Cannula

Interventions

CPAP

CPAP

Intervention Type: DEVICE

Nasal Cannula

Nasal Cannula

Intervention Type: DEVICE

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

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 36 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mansoura University Children's Hospital

Principal Investigators

Hesham Abdel Hady, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Children's Hospital

Locations

Mansoura University Children's Hospital

Al Mansurah, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 12076463 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12076445 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15930230 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19564301 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18977958 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17403854 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16855619 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15342841 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21276671 (View on PubMed)

Other Identifiers

20081230

Identifier Type: -

Identifier Source: org_study_id