Page tree
Skip to end of metadata
Go to start of metadata
Study

Contacts

GA/BW Criteria

Eligibility

Consent

Links

Daytime: Lisa Mravicich 021897982 or Chris McKinlay 0274725099

After hours: Chris McKinlay 0274725099


34+0 to 36+6 weeks

Inclusion:

  • <72 hours old

Exclusion:

  • Major congenital abnormality
  • Minor congenital abnormality likely to affect respiration, growth or development
  • Previous caffeine treatment
  • Renal or hepatic impairment
  • Tachyarrhythmia
  • Seizures
  • Hypoxic ischaemic encephalopathy
  • Residing outside of the Auckland DHB regions

Written informed consent prior to randomisation.



Randomisation

Databases

Consent Form

Protocol

Standard Operating Procedures

Study Handbook (inpatient)

Parent Brochure

Health Professional Brochure

Date calculator

Daytime: David Hou 021414888 or Lisa Mravicich 021897982

After hours: duty consultant

≥35 weeks

Inclusion:

  • <23 hours
  • One or more of the following: Apgar ≤ 5 at 10 mins after birth; OR receiving ongoing resuscitation at 10 mins after birth; OR  on cord blood or arterial/venous blood obtained at < 60 mins after birth,  pH less than 7.00 OR base deficit ≥ 12.0 mmol/L. 
  • Moderate to severe encephalopathy, defined between one and six hrs after birth by: 3 out of 6 modified Sarnat criteria indicating moderate/severe encephalopathy
  • Hypothermia treatment initiated by 6 hrs of age; Study treatment planned to start within 24 hrs after birth 
  • At least one parent ≥ 18 yrs old
  • Anticipated ability to collect primary endpoint at 2 yrs

Exclusion:

  • Severe IUGR (birth weight <1800 g) 
  • Suspected major chromosomal or congenital anomalies
  • HC <3rd centile below mean for GA & gender
  • Imminent withdrawal of care is being planned
Written informed consent prior to randomisation. Where this cannot be obtained in time to allow randomisation by 23 hours of age, telephone parental consent is acceptable, with signed consent obtained as soon as feasible. Protocol
  • No labels