Effect of Establishing Functional Residual Capacity During Newborn Resuscitation on Oxygenation

NCT00531102 | Terminated

• 1 other identifier: RT733739
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Resuscitation

Keywords

oxygen; continuous positive airway pressure; infant, newborn; resuscitation

Outcome Measures

Primary Outcomes (1)

• 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.

  5 minutes after birth

Secondary Outcomes (1)

• The secondary outcome measure is the proportion of infants achieving a stable oxygen saturation of ≥90%.

  10 minutes after birth

Study Arms (2)

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

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

Interventions

continuous positive airway pressure OTHER

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

1

Free flow oxygen OTHER

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

2

Eligibility Criteria

• Age: Up to 1 Minute
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• American Academy of Pediatrics: collaborator

Study Sites (1)

Foothills Hospital

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Yacov Rabi, MD, FRCPC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2007
• First Posted: September 18, 2007
• Study Start: February 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: October 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)