Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants

BronchoPulmonary Dysplasia Clinical Trial

— EASEOFFNCPAP  

Official title:

A Prospective Randomized Controlled Tiral Comparing Sprinting Versus Non-sprinting Approach to Wean Nasal Continous Positive Airway Pressure Support in Premature Infants Born at Less Than 30 Weeks Gestational Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819050
• Other study ID #: 30166-01
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: December 2021
• Source: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Though Nasal Continuous Positive Airway Pressure (NCPAP) is a commonly used form of non-invasive neonatal respiratory support, the optimal method of weaning off NCPAP is not well established. In this prospective, two-center randomized control trial we hypothesize that gradually increasing time off NCPAP (sprinting) increases the success of weaning NCPAP off in infants born between 23 0/7-30 6/7 weeks of gestational age.

Description:

Eligible infants admitted to two Neonatal Intensive Care Units (NICUs) were randomized to a sprinting (SP) vs. a non-sprinting (NSP) protocol, both over 4 days. Infants assigned to the SP group sprinted twice daily for 3h (day 1), 6h (day 2), 9h (day 3) & then 24h back on NCPAP (day 4) before switching to nasal cannula (NC) on day 5. Infants in the NSP group were maintained on NCPAP of 5 cm of water for the first 4 days before switching to NC on day 5, similar to the SP group. Infants in both groups were observed for the next 3 days (day 5-7) to ensure stability off CPAP

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Weeks and older

Eligibility

Inclusion Criteria:

• Born between 23 0/7 - 30 6/7 weeks GA
• At least 26 0/7 weeks corrected GA.
• On NCPAP for at least 24 hours
• Stable on =0.3 FiO2 for at least 24 hours Initiation of study protocol, i.e., weaning from NCPAP, was started when infant met all of

the following criteria for at least 24 hours:

• Requiring NCPAP of 4-6 cm of H2O and FiO2 =0.3.
• All babies < 32 weeks corrected GA should have been loaded or already on maintenance caffeine (caffeine citrate 20 mg/kg as the loading and 5-10 mg/kg as the maintenance dose).
• Stable respiratory system assessment (respiratory rate of < 70/min, no significant chest retractions (sternal/ diaphragmatic), and baseline oxygen saturation > 86%) and otherwise deemed clinically stable for weaning off non-invasive ventilation by medical team
• If post-surgery, infant must be at least 2 weeks post-operative and off antibiotics with no concern or need for repeat surgery.
• A documented hemoglobin of more than 8 g/dl within 7 days of initiation of the study.
• Meeting "stability criteria" defined below:
• The infant had to be tolerating a flow of no more than 2 liters NC on a FiO2 of 0.30 or less to keep oxygen saturations above 85% (should match what you wrote below in failure criteria)%.
• Have a respiratory rate of less than 70 on average over 24 hours for more than 24 hours
• The infant could have no significant chest recession (sternal/diaphragmatic)

Exclusion Criteria:

• Evidence of a hemodynamically or clinically significant (worsening respiratory status or pulmonary edema on chest x-ray) Patent ductus arteriosus, diagnosed either clinically or echocardiographically.
• Any significant congenital abnormality (abnormalities affecting a major organ system, airway, or musculoskeletal system).
• Hemodynamic/respiratory instability or currently being treated for suspected or proven sepsis (positive blood culture)
• Grade IV intraventricular hemorrhage
• Inability to obtain informed parental consent

Related Conditions & MeSH terms

• Birth Weight
• Bronchopulmonary Dysplasia
• Extremely Low Birth Weight Infant (ELBW)
• Hyaline Membrane Disease
• Neonatal Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• NCPAP
Nasal Continuous Positive Airway Pressure

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Children's Hospital of Orange County

References & Publications (9)

A Soe, J Hodgkinson, B Jani DAD. Nasal continous positive airway pressure weaning in preterm infants. Eur J Pediatr B Abstr Eur Acad Pediatr. 2006;Abstract.

Finer NN, Carlo WA, Duara S, Fanaroff AA, Donovan EF, Wright LL, Kandefer S, Poole WK; National Institute of Child Health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics. 2004 Sep;114(3):651-7. — View Citation

Jardine LA, Inglis GD, Davies MW. Strategies for the withdrawal of nasal continuous positive airway pressure (NCPAP) in preterm infants. Cochrane Database Syst Rev. 2011 Feb 16;(2):CD006979. doi: 10.1002/14651858.CD006979.pub2. Review. — View Citation

Rastogi S, Rajasekhar H, Gupta A, Bhutada A, Rastogi D, Wung JT. Factors Affecting the Weaning from Nasal CPAP in Preterm Neonates. Int J Pediatr. 2012;2012:416073. doi: 10.1155/2012/416073. Epub 2011 Dec 8. — View Citation

Rastogi S, Wong W, Gupta A, Bhutada A; Deepa Rastogi, Maimonides Neonatal Group. Gradual versus sudden weaning from nasal CPAP in preterm infants: a pilot randomized controlled trial. Respir Care. 2013 Mar;58(3):511-6. — View Citation

Singh SD, Bowe L, Clarke P, Glover K, Pasquill A R, MJ et al. Is decreasing pressure or increasing time off the better strategy in weaning VLBW infants from nasal CPAP? Eur J Pediatr B Abstr Eur Acad Pediatr. 2006;Abstract.

SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network, Finer NN, Carlo WA, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Donovan EF, Newman NS, Ambalavanan N, Frantz ID 3rd, Buchter S, Sánchez PJ, Kennedy KA, Laroia N, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Bhandari V, Watterberg KL, Higgins RD. Early CPAP versus surfactant in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1970-9. doi: 10.1056/NEJMoa0911783. Epub 2010 May 16. Erratum in: N Engl J Med. 2010 Jun 10;362(23):2235. — View Citation

Todd DA, Wright A, Broom M, Chauhan M, Meskell S, Cameron C, Perdomi AM, Rochefort M, Jardine L, Stewart A, Shadbolt B. Methods of weaning preterm babies <30 weeks gestation off CPAP: a multicentre randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2012 Jul;97(4):F236-40. doi: 10.1136/adc.2011-300133. Epub 2012 May 18. — View Citation

Vaucher YE, Peralta-Carcelen M, Finer NN, Carlo WA, Gantz MG, Walsh MC, Laptook AR, Yoder BA, Faix RG, Das A, Schibler K, Rich W, Newman NS, Vohr BR, Yolton K, Heyne RJ, Wilson-Costello DE, Evans PW, Goldstein RF, Acarregui MJ, Adams-Chapman I, Pappas A, Hintz SR, Poindexter B, Dusick AM, McGowan EC, Ehrenkranz RA, Bodnar A, Bauer CR, Fuller J, O'Shea TM, Myers GJ, Higgins RD; SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network. Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial. N Engl J Med. 2012 Dec 27;367(26):2495-504. doi: 10.1056/NEJMoa1208506. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Successful Wean Off CPAP at the First Attempt	Measured by successful wean off CPAP on first attempt, i.e., no NCPAP requirement after 7 days on wean protocol on first attempt.	7 days
Secondary	Number of Participants With Bronchopulmonary Dysplasia	Measured as an oxygen requirement at 36 weeks corrected gestational age	1-2 months
Secondary	Number of Participants With Retinopathy of Prematurity (ROP)	Measured as clinical signs of stage 2 or above ROP on retinal exam prior to discharge	1-2 months
Secondary	Number of Participants With Periventricular Leukomalacia (PVL)	Measured as radiologic findings of PVL noted prior to discharge	1-2 months
Secondary	Length of Stay (Days)	Measures as the number of days patient remained hospitalized after birth at the study hospital.	60-108 days
Secondary	Corrected Gestational Age at Time of Discharge/Transfer	Measured as the corrected gestational age at which the patient was discharged or transferred.	36weeks-41weeks
Secondary	Number of Attempts to Wean Off CPAP	Number of attempts made to wean off CPAP	Until completely weaned off CPAP
Secondary	Number of Days on Protocol	Measured as the total number of days the patient was on the study protocol	7-10 days