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 COMPLETED!!
Recruitment paused pending Phase 3 approval

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
Parent Discharge Information


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
PLATIPUS Video
BabyCCINO Video
Spinnaker
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)