Current Studies

ContactEligibilityLinks

Chris McKinlay 0274725099
Lisa Mravicich 021430564
Inclusion:
*34 to 36 weeks (must be <72 hours at randomisation)

Exclusion: 
*Major congenital malformation(s)
*Minor congenital abnormality affecting respiration, growth, or development
*Previous caffeine
*Renal or hepatic impairment
*Tachyarrhythmia
*Seizures
*Hypoxic ischaemic encephalopathy
*Mother <16 years

Nursing Guide
Screen & Randomise
Trial Data
PISC
Parent Brochure
Protocol

Neurologist 096316128
Chris McKinlay 0274725099
PHASE 2 LIVE
Screening:
In the following infants, start EEG, provide parent flyer and notify the study team:
*HIE stage 2 or 3
*Any therapeutic hypothermia
*Other encephalopathy, including meningitis
*Suspected seizure, including unexplained apnoea
*Moderate to severe metabolic acidosis (pH<7.0, base excess >12 mmol/L) at risk of encephalopathy (discuss with SMO if EEG appropriate)

Inclusion:
*≥35 weeks
*>2.2 kg
*Electrographic seizures (<8 minutes/hour)

Exclusion:
*Imminent death

Use of AED before enrolment:
If anti-seizure medication is required before enrolment, use IV midazolam (150 micrograms/kg).
If sedation is required, use morphine rather than midazolam.

Nursing Guide
Parent Flyer
PISC
PK Sample Documentation Form
PK Sample Lab Form
Parent Feedback Form
Links

Lisa Mravicich 021430564
Inclusion:
*<32 weeks or <1500 g
*Dry blood spot TSH above the screening threshold

Exclusions:
*Triplets
*Maternal thyroid disease requiring treatment with thyroxine, carbimazole or propylthiouracil
Known or strongly suspected syndromes with known thyroid abnormalities, e.g., Down syndrome
*Suspected or confirmed pituitary abnormalities
*Major congenital anomalies, receiving palliative care or critically unwell
PIS Cases
PIS Controls
Protocol
Assessments
COMING SOON!!Website
Video
DM2 CGM

Lisa Mravicich 021430564
RECRUITMENT COMPLETED!!

Inclusion:
*32+weeks’ gestation
*Type 2 Diabetes Mellitus
*Singleton pregnancy
Screen
Trial Data
PISC
RECRUITMENT COMPLETED!!
Follow-up continues until 2027

Inclusion:
*<32 weeks
*Singleton pregnancy
*Severe FGR: AC ≤3rd centile for gestational age OR
AC <10th centile and ≥1 abnormal fetoplacental Doppler (a: Uterine artery pulsatility index ≥95th centile or b: Umbilical artery pulsatility index ≥95th centile or absent/reversed end-diastolic flow)

Exclusion:
*Known fetal chromosomal or major structural anomaly, or non-placental cause of FGR
*Immediate delivery indicated, e.g., absent A wave in ductus venosus, preterminal CTG or biophysical profile
*Co-recruitment in another clinical trial where a pharmaceutical product or nutritional supplement impacting on oxidative stress is the trial intervention
*Currently prescribed Fluvoxamine
Screen
Randomise
Trial Data
Patient Video
Parent Brochure
PISC
Poster
Protocol
3,923 INFANTS RECRUITED!!
1-year follow-up completed
6-year follow-up continues until December 2028.

Inclusion:
*≥32 weeks
*<8 weeks old

Exclusion:
*Previous exposure to paracetamol or ibuprofen
*Chronic disease associated with limited life expectancy (<6 years)
*Likely to leave NZ in first 6 years
Databases
Parent Video
Protocol
Facebook
Website
RECRUITMENT COMPLETED!!
Early childhood follow-up continues until 2026.

Inclusion:
*<28 weeks
*<48 hours
*Surfactant, if given, <12 hours ago
*Receiving mechanical ventilation via an endotracheal tube OR receiving non-invasive respiratory support including CPAP, nasal IPPV or nasal high flow AND a clinical decision to treat with exogenous surfactant

Exclusion:
*Previous steroids for prevention of lung disease (steroids for hypotension is OK)
*Infant is considered non-viable
*Major congenital anomaly that is likely to affect respiratory status
*Severe pulmonary hypoplasia following PPROM with severe oligo/anhydramnios, where the clinician, based on clinical assessment on the first postnatal day, believes survival is unlikely
*More than one dose of previous surfactant
Trial Data
RECRUITEMENT COMPLETED!!
Follow-up continues until December 2026

Inclusion:
*<29 weeks
*Within 6 hours of blood culture taken for suspected LOS (>48 hours of age) or NEC. 

Exclusion: 
*Major congenital malformation(s) or chromosomal abnormalities.

Commence the study infusion within 6 hours of a blood culture being taken for EVERY episode of suspected LOS or NEC for the ENTIRE hospital stay.
*Infuse for 12 hours on days 1-2.
*Infuse for 6 hours on days 3-6 if proven LOS/NEC or probable LOS (antibiotics for ≥5 days AND raised CRP)