Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate - Full Text View

Purpose

This study is being done to evaluate if delaying cord clamping or milking the umbilical cord of the preterm infant has health benefits for the baby. Timing of clamping of the cord varies among doctors, but there is information that shows that delaying clamping of the umbilical cord in premature infants may reduce the rate of the baby needing a blood transfusion, decrease the risk of infection and bleeding in the head.

Condition	Intervention
Premature Birth	Procedure: Delayed cord clamping Procedure: Milking of the cord

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate - a Randomized, Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation

U.S. FDA Resources

Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:

Adverse Neonatal Event [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
composite of bronchopulmonary dysplasia (BPD), necrotising eneterocolitis (NEC), grade 3 or 4 intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL), or death prior to discharge home

Secondary Outcome Measures:

Maternal estimated blood loss [ Time Frame: up to 1 hour after delivery ] [ Designated as safety issue: Yes ]
Estimated blood loss at delivery
Any grade intraventricular hemorrhage [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
Severe intraventricular hemorrhage (grade 3 or 4) [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
Periventricular leukomalacia [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
Bronchopulmonary dysplasia [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
Peak transcutaneous and/or serum bilirubin concentrations [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: Yes ]
Phototherapy [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: Yes ]
Requirement and length of phototherapy
Ionotropic support [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
Requirement and length of ionotropic support
Neonatal intesive care unit (NICU) length of stay [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
Sepsis [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
Necrotizing enterocolitis [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
Respiratory distress syndrome [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
Number of blood transfusions while in the neonatal intensive care unit [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
Ventilator time [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
Apgar score <7 at 5 minutes [ Time Frame: at 5 minutes after birth ] [ Designated as safety issue: Yes ]
Umbilical cord pH < 7.0 [ Time Frame: up to 30 minutes after birth ] [ Designated as safety issue: Yes ]
Blood pressure on admission to neonatal intensive care unit [ Time Frame: at 30 minutes after birth ] [ Designated as safety issue: No ]
Polycythemia [ Time Frame: up to 24 hours of life ] [ Designated as safety issue: Yes ]
Hematocrit on admission to neonatal intensive care unit [ Time Frame: up to 4 hours after birth ] [ Designated as safety issue: No ]
Neonatal death [ Time Frame: up to 24 weeks of life ] [ Designated as safety issue: No ]
Length of 3rd stage of labor [ Time Frame: up to 1 hour after birth ] [ Designated as safety issue: Yes ]
Time period between delivery of the baby and delivery of the placenta
Use of uterotonic agents [ Time Frame: up to 1 hour after birth ] [ Designated as safety issue: Yes ]
Maternal blood transfusion [ Time Frame: up to 5 days after delivery ] [ Designated as safety issue: Yes ]
Manual removal of placenta [ Time Frame: up to 1 hour after birth ] [ Designated as safety issue: Yes ]
Operating time for cesarean delivery [ Time Frame: up to 3 hours after birth ] [ Designated as safety issue: Yes ]

Enrollment:	2
Study Start Date:	December 2011
Study Completion Date:	January 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Delayed cord clamping Delayed cord clamping for 30 seconds	Procedure: Delayed cord clamping Delay cord clamping for 30 seconds after birth
Experimental: Milking of the cord Milking of the cord 4 times in 10 seconds	Procedure: Milking of the cord Milking of the cord 4 times in 10 seconds
No Intervention: Immediate cord clamping Immediate cord clamping after delivery

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Singleton or multiples pregnancies in patients admitted for medically indicated delivery or in advanced spontaneous preterm labor with imminent delivery at 24 0/7 - 28 6/7 weeks gestation
Women ages 18 and older

Exclusion Criteria:

Planned vaginal breech delivery
Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery)
Fetal death in utero
Red cell isoimmunization
Patients who are incapable of informed consent (unconscious, severely ill, mentally handicapped), or are unwilling to undergo randomization
Placenta previa or other known abnormal placentation (e.g. placenta accreta)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393834

Sponsors and Collaborators

Medstar Research Institute

Investigators

Principal Investigator:

Rita W Driggers, MD

Washington Hospital Center, Georgetown University Hospital

More Information

No publications provided

Responsible Party:	Medstar Research Institute
ClinicalTrials.gov Identifier:	NCT01393834 History of Changes
Other Study ID Numbers:	2011-053
Study First Received:	June 1, 2011
Last Updated:	February 20, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Medstar Research Institute:

Delayed cord clamping
Umbilical cord
Preterm
Cord milking

Additional relevant MeSH terms:

Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on May 21, 2013