Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping) (PREMOD2FU)

Sharp HealthCare

Status: Enrolling

Conditions: Neurodevelopmental Abnormality

Treatments: Procedure: Randomized to Umbilical Cord Milking at birth; Procedure: Randomized to Delayed Cord Clamping at birth

Study type: Interventional

Funder types: Other

Identifiers

NCT03476980

PREMOD2 Follow-Up

Details and patient eligibility

About

An extension of the PREMOD2 trial, the PREMOD2 Follow-Up trial will evaluate the neurodevelopmental outcomes at 22-26 months corrected age of preterm children who received UCM or DCC. This prospective multi-national randomized controlled trial (RCT) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.

Full description

The PREMOD2 Follow-up trial will examine the difference in early childhood neurodevelopmental outcomes of subjects enrolled in the PREMOD2 umbilical cord milking (UCM) vs. delayed cord clamping (DCC) trial, using standardized neurologic and developmental assessments at 22-26 months corrected age (CA). The corrected age may be extended out to 42 months CA due to Covid-19 pandemic for undetermined period of time.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 22 to 42 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children enrolled in the PREMOD2 non-inferiority trial at birth who survive to 2 years corrected age.

Exclusion criteria

• Children enrolled in the PREMOD2 non-inferiority trial at birth who did not survive or are lost to follow-up.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,200 participants in 2 patient groups

Randomized to Umbilical Cord Milking at birth

Active Comparator group

Description:

Milking the umbilical cord towards the infant at a speed of 20cm/2seconds at birth.

Treatment:

Procedure: Randomized to Umbilical Cord Milking at birth

Randomized to Delayed Cord Clamping at birth

Active Comparator group

Description:

Delayed clamping of the umbilical cord at birth.

Treatment:

Procedure: Randomized to Delayed Cord Clamping at birth