NCT01305031

Brief Summary

In this randomized control trial, the investigators hypothesize that late-preterm infants resuscitated with a "low oxygen delivery" strategy (initiation of resuscitation with room air) will result in a significant reduction in oxidant stress without any harmful clinical effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 28, 2014

Status Verified

October 1, 2014

Enrollment Period

Same day

First QC Date

February 25, 2011

Last Update Submit

October 25, 2014

Conditions

Asphyxia

Keywords

AsphyxiaResuscitationRoom Air

Outcome Measures

Primary Outcomes (2)

  • oxidative stress status

    7 days

  • oxygen saturations

    10 min

Secondary Outcomes (12)

  • Days on oxygen

    28 days

  • Days on conventional ventilation

    28 days

  • Days on high frequency ventilation

    28 days

  • Days on nasal canula

    28 days

  • Pneumothorax

    28 days

  • +7 more secondary outcomes

Study Arms (2)

Room air

EXPERIMENTAL

Initiation of resuscitation with 21% Oxygen, adjustments to the inspired oxygen concentration (increased 10%) will be made every 60 seconds for infants to achieve a target SpO2 range of 85-92%

Other: Resuscitation

100% Oxygen

ACTIVE COMPARATOR

Initiation of resuscitation with 100% Oxygen and achieve oxygen saturation in the preset limits 85-92%

Other: 100% oxygen

Interventions

ResuscitationOTHER

Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-92%

Room air
100% oxygenOTHER

Use of 100% oxygen needed to achieve oxygen saturation in the preset limits 85-92%

100% Oxygen

Eligibility Criteria

Age34 Weeks - 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • inborn infant
  • gestation 34 weeks to 36 weeks 6 days

You may not qualify if:

  • known chromosomal or congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Maternal and Child Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Conditions

Asphyxia

Interventions

ResuscitationOxygen

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

Emergency TreatmentTherapeuticsChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Shuping Han, PhD

    Nanjing Medical University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 25, 2011

First Posted

February 28, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2011

Study Completion

December 1, 2011

Last Updated

October 28, 2014

Record last verified: 2014-10

Locations

CN(1)