Katheria 2017.

Trial name or title	Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2 (PREMOD2) and PREMOD2 With Near Infrared Spectroscopy Sub‐study (PREMOD2)
Methods	Randomised, parallel assignment. It is not possible to blind the delivering obstetrician, however all other caregivers will be blinded. The procedure will be documented as "placental transfusion" in the delivery summary or admission‐progress notes and all study assessments whether primary (head US) or secondary (neurodevelopmental exams) will be performed by blinded team members.
Participants	Inclusion criteria: Preterm infants ‐ 23 ‐ 31+6 weeks' gestation Multiples unless monochorionic Exclusion criteria: Congenital anomalies; major cardiac defects; placental abruption or previa with haemorrhage; cord prolapse; hydrops; bleeding accreta; monochorionic multiples (i.e. Di/Mo or Mo/Mo twins); fetal or maternal risk (i.e. compromise); parents declined study; unlikely to return for 2 yr follow up.
Interventions	Intervention: DCC Cord clamped at > 60 secs. Comparator: Umbilical cord milking UCM
Outcomes	Primary: Death or neurodevelopmental impairment at 2 years corrected gestational age Any intraventricular haemorrhage (grades 1‐4) Severe intraventricular haemorrhage (bleeding in the brain parenchyma and/or ventricular dilation) Hemoglobin/hematocrit at 4 hours Secondary: Delivery room interventions (Time frame: In the first 10 minutes of life) Resuscitation interventions including positive pressure ventilation, continuous positive airway pressure, intubation, chest compressions and medications Blood pressure on admission, 6, 12, 18 and 24 hours of life
Starting date	June 6, 2017
Contact information	Anup Katheria: Email: anup.katheria@sharp.com Kathy Arnell: Email: kathy.arnell@sharp.com
Notes	'Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2' Recruiting 1500 infants. Dates aiming for: June 2017 to Dec 2020 (complete 2022) Setting: Canada, Germany, Ireland, United States Sponsor: Sharp HealthCare Declarations of interest: Substudy: assessing Near IR spectroscopy for cerebral oxygenation in 400 infants. Comparison 5 and 6