Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure

NCT01093495 | Completed DMC

• 1 other identifier: 20081230
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Nasal Continuous positive Airway pressure; Nasal Cannula; CPAP; Premature; RDS; HMD; NICU

Outcome Measures

Primary Outcomes (1)

• Duration of oxygen use

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

  3 months

Secondary Outcomes (1)

• Length of respiratory support

  3 months

Study Arms (2)

CPAP group

EXPERIMENTAL

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.

Device: CPAP

Nasal Cannula Group

EXPERIMENTAL

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.

Device: Nasal Cannula

Interventions

CPAP DEVICE

CPAP

CPAP group

Nasal Cannula DEVICE

Nasal Cannula

Nasal Cannula Group

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Children's Hospital

Al Mansurah, Egypt

Location

Related Publications (9)

• 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.

  PMID: 12076463 BACKGROUND

• 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.

  PMID: 12076445 BACKGROUND

• 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.

  PMID: 15930230 BACKGROUND

• 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.

  PMID: 19564301 BACKGROUND

• 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.

  PMID: 18977958 BACKGROUND

• 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.

  PMID: 17403854 BACKGROUND

• 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.

  PMID: 16855619 BACKGROUND

• 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.

  PMID: 15342841 BACKGROUND

• 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.

  PMID: 21276671 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Hyaline Membrane Disease; Premature Birth

Interventions

Cannula

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Distress Syndrome, Newborn; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• Hesham Abdel Hady, MD

  Mansoura University Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 25, 2010
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: March 25, 2010

Record last verified: 2010-03

Locations

EG (1)