Delayed Cord Clamping in Premature Infants

Delayed Cord Clamping: Prevention of Anemia and Hypothermia in Premature Infants

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01018576

Enrollment

Registered

2009-11-23

Start date

2009-09-30

Completion date

2012-03-31

Last updated

2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Hypothermia

Keywords

delayed cord clamping, premature infants, hypothermia, anemia, intraventricular hemorrhage, Anemia in premature infants

Brief summary

Delayed cord clamping has been shown to decrease the risk of bleeding in the brain of premature infants. However this procedure is not standard due to concerns that the premature infant will get too cold. In this study the investigators look at using a plastic covering and a chemical warmer to keep the small premature baby warm while waiting 30-60 seconds to clamp the umbilical cord.

Detailed description

Enrolled premature infants will be compared to age matched historical controls that did not receive delayed cord clamping but were placed under a warmer immediately after birth. Outcomes to be analyzed include initial body temperature, hematocrit at birth and 24 hours of age, number of red blood cell transfusions during hospital stay, umbilical cord gas, first blood gas following delivery, blood pressure data in the first 24 hours, fluid bolus and inotrope requirement in the first 24 hours, incidence of intraventricular hemorrhage and late-onset sepsis, peak bilirubin level, length of phototherapy, and Apgar scores.

Interventions

OTHERDelayed cord clamping

Infants will be covered with plastic and placed on a chemical warmer at delivery and then clamping of the umbilical cord will be delayed for 30-60 seconds.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Minutes

Healthy volunteers

Inclusion criteria

* premature infants at 24-28 completed weeks gestation at the time of delivery * informed consent obtained from parents prior to delivery

Exclusion criteria

* multiple gestation (twins, triplets, etc) * prolonged fetal bradycardia * placental abruption or previa * maternal illness * major congenital anomalies * maternal fever in labor * fetal illness (e.g. isoimmune hemolysis)

Design outcomes

Primary

Measure	Time frame
Initial body temperature	At birth

Secondary

Measure	Time frame
Hematocrit at birth and 24 hours of age	first day of life

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026