CompletedNot Applicable

Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2

United States, Canada, Germany1,201 participantsStarted 2017-06-06

Plain-language summary

This study is being done to find out whether umbilical cord milking (UCM) is at least as good as or better than delayed cord clamping (DCC) to reduce bleeding in the brain or prevent death in premature newborns. The investigators will study short and long term outcomes of infants delivered before 32 weeks gestation that receive either UCM or DCC. \* The trial was stopped by the DSMB for safety in the small strata. They subsequently allowed for continuation of the trial in infants 29-32+6 wk GA.

Who can participate

Age range

23 Weeks – 33 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 23 to 32 +6 Gestational age (currently enrolling 29 to 32+6 weeks) * Multiples without Twin-to-twin Transfusion Syndrome (TTTS) Exclusion Criteria: * Congenital anomalies * Major cardiac defects * Placental abruption or previa with hemorrhage * Cord prolapse * Hydrops * Bleeding Accreta * Monochorionic multiples with evidence of TTTS * Fetal or maternal risk (i.e. compromise) * Parents declined study * Unlikely to return for 2 yr Follow Up

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of severe IVH or death

Timeframe: Through study completion at death or discharge, up to 6 months corrected gestational age (CGA)

Trial details

NCT IDNCT03019367

SponsorSharp HealthCare

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-16

View on ClinicalTrials.gov More Intraventricular Haemorrhage Neonatal trials