NCT01942967

Brief Summary

The purpose of this study is to examine the blood flow and the delivery of oxygen to the brain and gut in preterm babies while they are supported with two modes of breathing machine and compare these two methods to see if one allows for better blood flow to the brain and gut.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2013

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 19, 2013

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 4, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

July 19, 2013

Last Update Submit

August 3, 2015

Conditions

Respiratory Distress Syndrome

Keywords

NeonateHemodynamicTissue oxygenationNon invasive ventilation

Outcome Measures

Primary Outcomes (3)

  • Change in cardiac output

    Targeted neonatal Echocardiography will be done according to the guidelines accepted by the writing group of the American society of echocardiography in collaboration with associations of European pediatric cardiologists The following standard windows will be used: 1. Subcostal. 2. Apical. 3. Long and short axis parasternal. 4. Suprasternal Measurements: * Left ventricular output (LVO). * Right ventricular output (RVO).

    Day 3 of life till 2 months of age

  • Changes in Superior Mesenteric Artery and Middle Cerebral Artery Doppler flow.

    Day 3 of life till 2 months of age

  • Cerebral and mesenteric regional tissue oxygenation

    Cerebral and mesenteric rSO2 trends and data (obtained by NIRS) will be recorded along with simultaneous pulse oximeter trends and data. The splanchnic-cerebral oxygenation ratio (SCOR) reflecting the ratio between regional cerebral oxygen saturation(rcSO2) and regional splanchnic oxygen saturation (rsSO2)(rcSO2/rsSO2) will be analyzed.

    Day 3 of life till 2 months of age

Study Arms (1)

Preterm ≤ 32 weeks GA, on CPAP

Preterm infants less than 32 weeks gestational age requiring CPAP as a mode of respiratory support and admitted in the NICU.While the baby is on CPAP,tissue oxygen saturation monitoring will be started by applying NIRS(Near Infrared Spectroscopy Monitoring) sensors to the forehead and the abdomen. After 3 hours,echocardiography(including Superior Mesenteric Artery Doppler) will be done while the baby is on CPAP. Then, using the same machine, the mode of respiratory support will be changed to TrPA. After another three hours,another echocardiography will be done,then NIRS monitoring will be stopped and the mode of respiratory support will be changed back to CPAP.

Other: EchocardiographyOther: Near Infrared Spectroscopy Monitoring

Interventions

EchocardiographyOTHER

Measurement of: * Left ventricular output (LVO). * Right ventricular output (RVO). * Assessment of the Mesenteric Artery Flow.

Preterm ≤ 32 weeks GA, on CPAP
Near Infrared Spectroscopy MonitoringOTHER

Measurement of cerebral and mesenteric regional oxygen saturation(rSO2) trends and data while the baby on CPAP or TrPA modes of noninvasive ventilation.

Also known as: NIRS
Preterm ≤ 32 weeks GA, on CPAP

Eligibility Criteria

Age48 Hours - 2 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Newborn infants less than 34 weeks gestational age at birth Requiring CPAP or TrPA as a mode of respiratory support

You may qualify if:

  • Preterm infants less than 34 weeks gestational age
  • Requirement of CPAP or TrPA as a mode of respiratory support

You may not qualify if:

  • Lack of parental consent
  • Preterm infants more than 34 gestational weeks
  • Preterm infants with congenital malformation
  • Severe perinatal asphyxia
  • Hemodynamically significant patent ductus arteriosus (PDA)
  • Pulmonary hypertension
  • Septic shock
  • Any associated congenital heart diseases other than non-significant PDA or patent foramen ovale (PFO)
  • Stage 2 or 3 necrotising enterocolitis (NEC)
  • Intraventricular hemorrhage (IVH) grade 3 or 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Health Sciences Center

Winnipeg, Manitoba, R3A 1S1, Canada

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Ganesh Srinivasan, MD

    University of Manitoba

    STUDY DIRECTOR

  • Mary S Seshia, MD

    University of Manitoba

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow, Perinatal-Neonatal Medicine

Study Record Dates

First Submitted

July 19, 2013

First Posted

September 16, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 4, 2015

Record last verified: 2015-08

Locations

CA(2)