Effect of Establishing Functional Residual Capacity During Newborn Resuscitation on Oxygenation - Full Text View

Sponsors and Collaborators:	University of Calgary American Academy of Pediatrics
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00531102

Purpose

Currently, newborns receive 100% supplemental oxygen by free flow when they remain cyanotic despite demonstrating regular respiratory effort. Resuscitating infants with continuous positive airway pressure (CPAP) in room air may improve oxygen saturations more quickly than providing FFO2 because of its ability to establish functional residual capacity in the lungs. Our primary hypothesis is that in this blinded, randomized control trial, more infants (≥35 weeks gestation) resuscitated with CPAP in room air will have an oxygen saturation ≥80% at five minutes of age compared to infants resuscitated with the 50% FFO2.

Condition	Intervention
Transition at Birth	Other: continuous positive airway pressure Other: Free flow oxygen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of Oxygen and Functional Residual Capacity on the Oxygen Saturations of Infants ≥ 35 Weeks Gestation During Delivery Room Resuscitation.

Further study details as provided by University of Calgary:

Primary Outcome Measures:

The primary outcome measure is the proportion of infants achieving a stable oxygen saturation of ≥80%. To be considered stable, the oxygen saturation must remain at or above the predetermined target saturation for at least 30 seconds. [ Time Frame: 5 minutes after birth ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary outcome measure is the proportion of infants achieving a stable oxygen saturation of ≥90%. [ Time Frame: 10 minutes after birth ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	220
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Resuscitation will proceed as per standard of care and infants are only to receive respiratory support if they remain cyanotic despite 60 seconds of spontaneous regular respirations. All infants will have a pulse oximetry probe placed on the right hand (pre-ductal position) immediately after birth. Infants that meet the entry criteria will be randomized to resuscitation with one of two neonatal T-piece resuscitator circuits: GROUP 1 - infants will receive CPAP of 6 cm H2O with 21% oxygen continuously for at least 5 minutes.	Other: continuous positive airway pressure Infants will receive CPAP of 6 cm H2O with 21% oxygen continuously for at least 5 minutes
2: Active Comparator Resuscitation will proceed as per standard of care and infants are only to receive respiratory support if they remain cyanotic despite 60 seconds of spontaneous regular respirations. Infants that meet the entry criteria will be randomized to resuscitation with one of two neonatal T-piece resuscitator circuits: GROUP 2 - infants will receive 50% oxygen at a rate of 6 liters per minute continuously for at least 5 minutes using a modified neonatal T-piece resuscitator circuit that does not generate pressure. Fifty percent oxygen was chosen because it reflects the actual inspired oxygen concentration when 100% oxygen is blown towards the infant's face.	Other: Free flow oxygen Infants will receive 50% oxygen delivered by a modified neonatal T-piece resuscitator circuit that does not generate pressure for at least 5 minutes.

Arms

Assigned Interventions

1: Experimental

Resuscitation will proceed as per standard of care and infants are only to receive respiratory support if they remain cyanotic despite 60 seconds of spontaneous regular respirations. All infants will have a pulse oximetry probe placed on the right hand (pre-ductal position) immediately after birth. Infants that meet the entry criteria will be randomized to resuscitation with one of two neonatal T-piece resuscitator circuits:

GROUP 1 - infants will receive CPAP of 6 cm H2O with 21% oxygen continuously for at least 5 minutes.

Other: continuous positive airway pressure

Infants will receive CPAP of 6 cm H2O with 21% oxygen continuously for at least 5 minutes

2: Active Comparator

Resuscitation will proceed as per standard of care and infants are only to receive respiratory support if they remain cyanotic despite 60 seconds of spontaneous regular respirations. Infants that meet the entry criteria will be randomized to resuscitation with one of two neonatal T-piece resuscitator circuits:

GROUP 2 - infants will receive 50% oxygen at a rate of 6 liters per minute continuously for at least 5 minutes using a modified neonatal T-piece resuscitator circuit that does not generate pressure. Fifty percent oxygen was chosen because it reflects the actual inspired oxygen concentration when 100% oxygen is blown towards the infant's face.

Other: Free flow oxygen

Infants will receive 50% oxygen delivered by a modified neonatal T-piece resuscitator circuit that does not generate pressure for at least 5 minutes.

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 1 Minute
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Inborn
≥35 weeks gestational age
Neonatal resuscitation team present at delivery
Central cyanosis despite 60 seconds of spontaneous respirations in room air. Sustained respirations are defined as: spontaneous breathing that is regular in rhythm and sufficient to maintain a heart rate ≥100 beats per minute such that provision of artificial tidal volume breathing is not required.

Exclusion Criteria:

Lethal anomalies
Cyanotic congenital heart disease
Known hemoglobinopathy
Risk of persistent pulmonary hypertension (eg, meconium aspiration, conditions associated with pulmonary hypoplasia such as prolonged)
Known anatomical lung abnormalities
Conditions where CPAP is contraindicated (eg, congenital diaphragmatic hernia). Mode of delivery will not be a criterion for inclusion or exclusion.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531102

Contacts

Contact: Yacov Rabi, MD, FRCPC

403-944-1615

jack.rabi@calgaryhealthregion.ca

Locations

Canada, Alberta
Foothills Hospital	Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Yacov Rabi, MD, FRCPC 403-944-1615 jack.rabi@calgaryhealthregion.ca
Sub-Investigator: Nalini Singhal, MD, FRCPC
Sub-Investigator: Amuchou Soraisham, MD, DM

Sponsors and Collaborators

University of Calgary

American Academy of Pediatrics

Investigators

Principal Investigator:

Yacov Rabi, MD, FRCPC

University of Calgary

More Information

Responsible Party:	University of Calgary ( Yacov Rabi MD )
Study ID Numbers:	RT733739
Study First Received:	September 17, 2007
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00531102
Health Authority:	Canada: Health Canada

Keywords provided by University of Calgary:

oxygen
continuous positive airway pressure
infant, newborn
resuscitation

ClinicalTrials.gov processed this record on January 16, 2009