# Premature Infants Receiving Cord Milking Or Delayed Cord Clamping

> **NIH NIH R01** · SHARP MEMORIAL HOSPITAL · 2020 · $572,495

## Abstract

BACKGROUND: Preterm brain injury from intraventricular hemorrhage (IVH) is a pressing worldwide public
health problem. Over 12,000 premature newborns develop IVH every year in the US alone. Delaying clamping
the umbilical cord at birth for 30-60 seconds provides the newborn with a significant autologous transfusion of
blood from the placenta and has been shown to reduce IVH. Delayed cord clamping (DCC) has been shown
to reduce overall IVH (mainly lower grades 1 and 2) by 50 percent, but has not reduced the incidence of severe
IVH or death. This may reflect inadequate placental transfusion for newborns delivered by Cesarean section
(C/S), the most common mode of delivery for very preterm infants. In 3 DCC trials an increased placental
transfusion was evident in infants born by vaginal delivery (V/D), but no or minimal transfusion in infants delivered
by C/S. We evaluated a technique – umbilical cord milking (UCM) – which provides a placental transfusion by
grasping the unclamped umbilical cord and pushing blood towards the newborn several times before the cord is
clamped. Our Phase 1 pilot trial (PREMOD) compared UCM to DCC in premature newborns delivered by C/S
and V/D. Results were equivalent for V/D. UCM improved blood flow and organ perfusion in C/S infants.
SPECIFIC AIMS: The specific aims of this trial are:
Aim 1. To compare the incidence of severe IVH and/or death in premature newborns <32 weeks GA delivered
by C/S receiving UCM to those receiving DCC.
Aim 2. To compare the safety and efficacy profiles of premature newborns <32 weeks GA delivered by C/S
receiving UCM vs. DCC during their hospitalization and at 24 months corrected age.
Aim 3. To compare the outcomes of premature newborns <32 weeks GA delivered by C/S (from Aims 1 and 2)
with those born by V/D receiving UCM or DCC.
DESIGN: This trial has a 2-tiered approach that will first demonstrate that the incidence of severe IVH and/or
death in premature newborns <32 weeks delivered by C/S with UCM is equivalent to DCC (non-inferiority), and
then test whether there is a decreased incidence of severe IVH and/or death with UCM (superiority). This
approach is being used in other neonatal trials, is endorsed by the FDA, and can be done within the scope and
sample of the proposed trial. DCC: The obstetrician will wait at least 60 seconds to clamp the cord. UCM: The
obstetrician will milk about 20 cm of umbilical cord four times over 2 seconds each. Brain oxygenation will be
recorded for the first 72 hours of life. Outcomes will include resuscitation interventions and neurodevelopmental
follow-up at 2 years. UCM is simple and allows resuscitation of the most critical infants without delay, which
justifies its use, even if UCM is equivalent to DCC. Optimal umbilical cord management in premature newborns
is an area that urgently needs scientific evidence to establish clear guidelines worldwide.

## Key facts

- **NIH application ID:** 9914830
- **Project number:** 5R01HD088646-04
- **Recipient organization:** SHARP MEMORIAL HOSPITAL
- **Principal Investigator:** Anup C Katheria
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $572,495
- **Award type:** 5
- **Project period:** 2017-04-01 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9914830

## Citation

> US National Institutes of Health, RePORTER application 9914830, Premature Infants Receiving Cord Milking Or Delayed Cord Clamping (5R01HD088646-04). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9914830. Licensed CC0.

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