Assessment of Lung Aeration at Birth

NCT01739114 | Completed DMC

• 1 other identifier: Pro00034524
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if respiratory support at birth guided by RFM decreases BPD.

Conditions

Bronchopulmonary Dysplasia

Keywords

Lung aeration; Bronchopulmonary dysplasia; Positive Pressure Respiration; Sustained Inflation; Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• Difference in bronchopulmonary dysplasia

  Difference in bronchopulmonary dysplasia as defined by need for oxygen or respiratory support at 36 weeks corrected gestational age.

  36 weeks corrected gestational age

Secondary Outcomes (2)

• Neonatal death < 28 days

  < 28 days

• Death before discharge

  before discharge from the NICU

Study Arms (2)

"SI group"

EXPERIMENTAL

Infants randomized into the "SI group" will receive two initial sustained inflations with a PIP of 20 cm H2O. After the two initial SIs infants will receive PEEP of 5 cm H2O and then CPAP if breathing spontaneously or, if found to have apnea or laboured breathing, mask IPPV with a PIP of 20 cm H2O and PEEP of 5 cm H2O at a rate of 40 to 60 bpm until spontaneously breathing, at which time CPAP will be provided.

Procedure: SI group

IPPV group

ACTIVE COMPARATOR

Infants randomized into the "IPPV group" will receive mask IPPV with an initial PIP of 20 cmH2O and PEEP of 5 cm H2O, and a ventilation rate of 40-60 inflations/min until spontaneously breathing, at which time CPAP will be provided.

Procedure: "IPPV group"

Interventions

"IPPV group" PROCEDURE

Infants randomized into the "IPPV group" will receive mask IPPV with an initial PIP of 20 cmH2O and PEEP of 5 cm H2O, and a ventilation rate of 40-60 inflations/min until spontaneously breathing, at which time CPAP will be provided.

IPPV group

SI group PROCEDURE

Infants randomized into the "SI group" will receive two initial sustained inflations with a PIP of 20 cmH2O. After the two initial SIs infants will receive PEEP of 5 cm H2O and then CPAP if breathing spontaneously or, if found to have apnea or laboured breathing, mask IPPV with a PIP of 20 cmH2O and PEEP of 5 cmH2O at a rate of 40 to 60 bpm until spontaneously breathing, at which time CPAP will be provided

"SI group"

Eligibility Criteria

• Age: Up to 30 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants \<33 weeks gestation born in the Royal Alexandra Hospital who require respiratory support for resuscitation in the delivery room.

You may not qualify if:

• Infants will be excluded if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, e.g. congenital pulmonary or airway anomalies, congenital diaphragmatic hernia, or congenital heart disease requiring intervention in neonatal period. Infants will also be excluded if their parents refuse to give consent to this study.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5K3V9, Canada

Location

Related Publications (19)

• Shah PS, Sankaran K, Aziz K, Allen AC, Seshia M, Ohlsson A, Lee SK; Canadian Neonatal Network. Outcomes of preterm infants <29 weeks gestation over 10-year period in Canada: a cause for concern? J Perinatol. 2012 Feb;32(2):132-8. doi: 10.1038/jp.2011.68. Epub 2011 May 19.

  PMID: 21593814 BACKGROUND

• Baraldi E, Filippone M. Chronic lung disease after premature birth. N Engl J Med. 2007 Nov 8;357(19):1946-55. doi: 10.1056/NEJMra067279. No abstract available.

  PMID: 17989387 BACKGROUND

• Kattwinkel J, Perlman JM, Aziz K, Colby C, Fairchild K, Gallagher J, Hazinski MF, Halamek LP, Kumar P, Little G, McGowan JE, Nightengale B, Ramirez MM, Ringer S, Simon WM, Weiner GM, Wyckoff M, Zaichkin J. Part 15: neonatal resuscitation: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S909-19. doi: 10.1161/CIRCULATIONAHA.110.971119. No abstract available.

  PMID: 20956231 BACKGROUND

• Schmolzer GM, Te Pas AB, Davis PG, Morley CJ. Reducing lung injury during neonatal resuscitation of preterm infants. J Pediatr. 2008 Dec;153(6):741-5. doi: 10.1016/j.jpeds.2008.08.016. No abstract available.

  PMID: 19014815 BACKGROUND

• Jobe AH. The New BPD. NeoReviews. 2006 Oct 1;7(10):e531-45.

  BACKGROUND

• Boon AW, Milner AD, Hopkin IE. Lung expansion, tidal exchange, and formation of the functional residual capacity during resuscitation of asphyxiated neonates. J Pediatr. 1979 Dec;95(6):1031-6. doi: 10.1016/s0022-3476(79)80304-2.

  PMID: 387935 BACKGROUND

• Vyas H, Milner AD, Hopkin IE, Boon AW. Physiologic responses to prolonged and slow-rise inflation in the resuscitation of the asphyxiated newborn infant. J Pediatr. 1981 Oct;99(4):635-9. doi: 10.1016/s0022-3476(81)80279-x.

  PMID: 7277110 BACKGROUND

• Lindner W, Vossbeck S, Hummler H, Pohlandt F. Delivery room management of extremely low birth weight infants: spontaneous breathing or intubation? Pediatrics. 1999 May;103(5 Pt 1):961-7. doi: 10.1542/peds.103.5.961.

  PMID: 10224173 BACKGROUND

• Lista G, Fontana P, Castoldi F, Cavigioli F, Dani C. Does sustained lung inflation at birth improve outcome of preterm infants at risk for respiratory distress syndrome? Neonatology. 2011;99(1):45-50. doi: 10.1159/000298312. Epub 2010 Jul 9.

  PMID: 20616570 BACKGROUND

• te Pas AB, Walther FJ. A randomized, controlled trial of delivery-room respiratory management in very preterm infants. Pediatrics. 2007 Aug;120(2):322-9. doi: 10.1542/peds.2007-0114.

  PMID: 17671058 BACKGROUND

• te Pas AB, Siew M, Wallace MJ, Kitchen MJ, Fouras A, Lewis RA, Yagi N, Uesugi K, Donath S, Davis PG, Morley CJ, Hooper SB. Effect of sustained inflation length on establishing functional residual capacity at birth in ventilated premature rabbits. Pediatr Res. 2009 Sep;66(3):295-300. doi: 10.1203/PDR.0b013e3181b1bca4.

  PMID: 19542905 BACKGROUND

• Siew ML, Te Pas AB, Wallace MJ, Kitchen MJ, Lewis RA, Fouras A, Morley CJ, Davis PG, Yagi N, Uesugi K, Hooper SB. Positive end-expiratory pressure enhances development of a functional residual capacity in preterm rabbits ventilated from birth. J Appl Physiol (1985). 2009 May;106(5):1487-93. doi: 10.1152/japplphysiol.91591.2008. Epub 2009 Mar 26.

  PMID: 19325025 BACKGROUND

• Schmolzer GM, Morley CJ, Wong C, Dawson JA, Kamlin CO, Donath SM, Hooper SB, Davis PG. Respiratory function monitor guidance of mask ventilation in the delivery room: a feasibility study. J Pediatr. 2012 Mar;160(3):377-381.e2. doi: 10.1016/j.jpeds.2011.09.017. Epub 2011 Nov 5.

  PMID: 22056350 BACKGROUND

• Dawson JA, Schmolzer GM, Kamlin CO, Te Pas AB, O'Donnell CP, Donath SM, Davis PG, Morley CJ. Oxygenation with T-piece versus self-inflating bag for ventilation of extremely preterm infants at birth: a randomized controlled trial. J Pediatr. 2011 Jun;158(6):912-918.e1-2. doi: 10.1016/j.jpeds.2010.12.003. Epub 2011 Jan 15.

  PMID: 21238983 BACKGROUND

• Dawson JA, Kamlin CO, Vento M, Wong C, Cole TJ, Donath SM, Davis PG, Morley CJ. Defining the reference range for oxygen saturation for infants after birth. Pediatrics. 2010 Jun;125(6):e1340-7. doi: 10.1542/peds.2009-1510. Epub 2010 May 3.

  PMID: 20439604 BACKGROUND

• Rabi Y, Singhal N, Nettel-Aguirre A. Room-air versus oxygen administration for resuscitation of preterm infants: the ROAR study. Pediatrics. 2011 Aug;128(2):e374-81. doi: 10.1542/peds.2010-3130. Epub 2011 Jul 11.

  PMID: 21746729 BACKGROUND

• 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, Sanchez 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.

  PMID: 20472939 BACKGROUND

• Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB; COIN Trial Investigators. Nasal CPAP or intubation at birth for very preterm infants. N Engl J Med. 2008 Feb 14;358(7):700-8. doi: 10.1056/NEJMoa072788.

  PMID: 18272893 BACKGROUND

• Ngan AY, Cheung PY, Hudson-Mason A, O'Reilly M, van Os S, Kumar M, Aziz K, Schmolzer GM. Using exhaled CO2 to guide initial respiratory support at birth: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2017 Nov;102(6):F525-F531. doi: 10.1136/archdischild-2016-312286. Epub 2017 Jun 8.

  PMID: 28596379 DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Georg Schmolzer, MD,PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Neonatologist, Postdoctoral Fellow

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: December 3, 2012
• Study Start: May 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 15, 2017

Record last verified: 2017-03

Locations

CA (1)