Hypothermia During ECMO to Decrease Brain Injury

NCT01675388 | Withdrawn

• 1 other identifier: 1006008466
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Newborn infants with severe respiratory failure are treated with extracorporeal membrane oxygenation (ECMO), a modified form of cardiopulmonary bypass. These infants as at risk for brain injury as a result of hypoxia and blood flow changes in the brain prior to and during ECMO. The investigators propose a clinical trial of a novel treatment (cooling during ECMO) and novel diagnostic tool (advanced MRI techniques) that will lead to improved outcomes, early diagnosis and intervention for brain injury, decreased cost and duration of clinical trials, decrease in the burden of chronic neurologic disease and disability in society, thus improving the health and quality of life of these infants as they progress through childhood into adulthood.

Conditions

Neonatal Respiratory Failure

Keywords

Neonatal hypoxemic respiratory failure; Extra Corporeal Membrane Oxygenation; Neurodevelopmental outcomes; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• BSID-III cognitive scores at 18-22 mo

  18-22 months of age

Secondary Outcomes (2)

• Clinical findings in the neonatal period and at 18-22 mos

  18-22 months

• MRI findings in the neonatal period and at 18-22 mos

  18-22 months

Study Arms (1)

Hypothermia

EXPERIMENTAL

Hypothermia to 33.5 deg Centigrade

Other: Hypothermia

Interventions

Hypothermia OTHER

Hypothermia to 33.5 deg C

Hypothermia

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates ≥ 34 weeks gestational age and postnatal age ≤ 28 days
• Presence of severe reversible NHRF qualifying for ECMO based on institutional guidelines including:
• Oxygenation Index \> 35 (\[mean airway pressure in cmH2O x Fractional inspired O2 concentration x 100\]/Arterial O2 tension in mmHg) or
• Alveolar-arterial oxygen gradient \> 600 mmHg for 4 h
• Infants undergoing veno-arterial or veno-venous ECMO

You may not qualify if:

• Lethal chromosomal and congenital anomalies including congenital diaphragmatic hernia (CDH) Infants with CDH, who constitute a third of neonates undergoing ECMO, have been excluded because the high mortality and morbidity is related more to the underlying lung abnormality and practice variation in timing of CDH repair rather than to NHRF.
• ECMO for post operative cardiac support
• Neonates with a birth weight \< 1.8 kg
• Initiation of HYP for NE prior to initiating ECMO for NHRF

Sponsors & Collaborators

• Sood, Beena G., MD, MS: lead

Study Sites (1)

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Study Officials

• Beena G. Sood

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: August 30, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

US (1)