A study in newborn children in need for intensive treatment resulting from insufficient oxygen supply to the brain.

• Conditions: Perinatal asphyxia; MedDRA version: 14.1Level: LLTClassification code 10004943Term: Birth asphyxiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 14.1Level: LLTClassification code 10003500Term: Asphyxia neonatalSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-002502-74-LT
• Lead Sponsor: europhyxia B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-10
• Last Update Posted: 8 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Subjects must meet all of the following requirements prior to inclusion in the study:
1.Neonates with = 36 and <44 gestation with at least one of the following:
•Apgar Score = 5 at 10 minutes after birth
•Continued need for resuscitation, including endotracheal or mask ventilation at 10 minutes after birth
•Acidosis defined as either umbilical cord pH or any arterial, venous, capillary pH within 60 minutes of birth pH = 7,00
•Acidosis defined as base deficit = 16 mmol/l in umbilical blood sample or any blood sample within 60 minutes of birth (arterial or venous).
2.The presence of moderate/severe encephalopathy defined as:
•Altered state of consciousness (lethargy, stupor, coma) and at least one of the following:
- Hypotonia
- Abnormal reflexes including oculomotor or papillary abnormalities
- Weak or absent suck reflex
- Clinical seizures
•AND depression of the background pattern (lower margin= 5 µV meaning at least DNV or BS, CLV, FT) or the presence of seizure activity on the aEEG, registered for at least 30 minutes within 6 hours after birth.
3.Presence in hospital and ability to start treatment within 6 hours after birth.
4.Informed Consent Form signed before first study-related activity according to local law. The Law on Ethics of Biomedical research of the Republic of Lithuania Lithuanian law art. 7 para.2 , states that both parents of the minor should give informed consent before a minor can be included in a study. If there is only a mother (i.e. divorce, unknown father), the Informed Consent Form should be signed by the mother.
5.Receiving standard therapy without hypothermia.

Are the trial subjects under 18? yes
Number of subjects for this age range: 66
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects meeting one or more of the following criteria cannot be included
1.Major antenatally known- or congenital abnormalities, such as hernia diaphragmatica requiring ventilation.
2.Major antenatally known chromosomal abnormalities, such as trisomy 13 or 18 or neonates with evident syndromal appearances including brain dysgenesis.
3.Severe growth restriction with a birth weight below the 3rd percentile.
4.Inability to insert an indwelling catheter (umbilical venous catheter or percutaneously inserted central catheter, preferably multiple lumen).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified