NCT01426698

Brief Summary

The purpose of this study is to examine differences in the long-term effects of immediate versus delayed cord clamping at birth on developmental outcomes of our study infants at 18-22 months corrected age.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 31, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

2.6 years

First QC Date

August 19, 2011

Last Update Submit

December 3, 2014

Conditions

Developmental Delay

Keywords

delayed cord clampingdevelopmental delay

Outcome Measures

Primary Outcomes (1)

  • Motor function

    Very low birth weight infants in the delayed cord-clamping group will have better motor function at 18-22 months corrected age when compared with VLBW infants in the ICC group.

    18-22 months

Secondary Outcomes (1)

  • Mental Functioning

    18 to 22 months

Study Arms (2)

Immediate cord clamping

ACTIVE COMPARATOR

Infants in this arm will have had immediate cord clamping at birth which is routine care at the hospital

Procedure: delayed cord clamping

Delayed Cord Clamping

EXPERIMENTAL

Intervention: Following the delivery of the infant, the obstetrician holds the infant approximately 10-15 inches below the mother's introitus at vaginal delivery or 10 to 15 inches below the level of the placenta at Cesarean section. The research nurse records the time when the infant's buttocks are delivered from the vagina or the uterus and counts out the time elapsed in ten second intervals to the obstetrician while he/she is doing the suctioning and drying maneuvers. At 30 to 45 seconds, the obstetrician milks the umbilical cord once, clamps, and cuts it. If the baby appears jeopardized in any way, the obstetrician can alter the protocol for the safety of the infant.

Procedure: delayed cord clamping

Interventions

delayed cord clampingPROCEDURE

at birth, the obstetrical provider delays the cord clamping for 45 seconds while lowering the infant. At 45 seconds the cord is milked once and then clamped and cut.

Also known as: DCC
Delayed Cord ClampingImmediate cord clamping

Eligibility Criteria

Age24 Weeks - 31 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • pregnancy between 24 and 31.6 weeks
  • singleton fetus
  • threatened preterm birth.

You may not qualify if:

  • Fetuses: congenital anomalies
  • Mothers: severe or multiple maternal illnesses
  • Drug users or institutionalized or psychotic women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Related Publications (3)

  • Mercer JS, Vohr BR, Erickson-Owens DA, Padbury JF, Oh W. Seven-month developmental outcomes of very low birth weight infants enrolled in a randomized controlled trial of delayed versus immediate cord clamping. J Perinatol. 2010 Jan;30(1):11-6. doi: 10.1038/jp.2009.170. Epub 2009 Oct 22.

    PMID: 19847185BACKGROUND

  • Wang M, Mercer JS, Padbury JF. Delayed Cord Clamping in Infants with Suspected Intrauterine Growth Restriction. J Pediatr. 2018 Oct;201:264-268. doi: 10.1016/j.jpeds.2018.05.028. Epub 2018 Jun 25.

    PMID: 29954605DERIVED

  • Mercer JS, Erickson-Owens DA, Vohr BR, Tucker RJ, Parker AB, Oh W, Padbury JF. Effects of Placental Transfusion on Neonatal and 18 Month Outcomes in Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jan;168:50-55.e1. doi: 10.1016/j.jpeds.2015.09.068. Epub 2015 Nov 4.

    PMID: 26547399DERIVED

MeSH Terms

Conditions

Learning Disabilities

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Judith S Mercer, PhD, CNM

    Women and Infants Hospital of Rhode Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 19, 2011

First Posted

August 31, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2014

Study Completion

December 1, 2014

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations

US(1)