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Effects of Delayed Cord Clamping in Very Low Birth Weight Infants

Primary Purpose

Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intraventricular Hemorrhage

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

delayed cord clamping

About this trial

This is an interventional prevention trial for Bronchopulmonary Dysplasia focused on measuring delayed cord clamping, very low birthweight infant, bronchopulmonary dysplasia, intraventricular hemorrhage, motor function

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women pregnant with gestation 24 to 31.6 weeks of singleton pregnancy by obstetrical evaluation
Obstetrician's approval of enrollment into study
Parental consent
Any mode of birth will be included

Exclusion Criteria:

Obstetrician's refusal to enroll infants
Parental refusal for consent
Prenatally-diagnosed major congenital anomalies [or multiple gestations]
Intent to withhold or withdraw care
Severe or multiple maternal illnesses, frank vaginal bleeding, placenta abruption or previa
Mothers who are institutionalized or psychotic

Sites / Locations

Women & Infants Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1-Immediate Cord Clamping

2-Delayed Cord Clamping

Arm Description

infants received the routine care of immediate clamping of the umbilical cord

after birth, cord clamping was delayed 30 to 45 seconds while infant was held lower than the level of the placenta.

Outcomes

Primary Outcome Measures

VLBW infants in the delayed clamped group will have less chronic lung disease at 36 weeks postmenstrual age compared to VLBW infants in the immediate cord clamped grouped

VLBW infants in the delayed clamped group will have fewer incidences of suspected necrotizing enterocolitis during the NICU stay when compared with VLBW infants in the immediate cord clamped group

VLBW infants in the delayed clamped group will have better motor function by 6 to corrected age when compared with VLBW infants in the immediate cord clamped group

Secondary Outcome Measures

Infants in the delayed cord clamping group will have less IVH than infants in the immediate clamping group

Infants in the delayed clamping group will hvae less late onset sepsis than infants in the immediate clamping group.

Full Information

NCT ID

NCT00840983

First Posted

February 10, 2009

Last Updated

November 27, 2015

Sponsor

University of Rhode Island

Collaborators

National Institute of Nursing Research (NINR), Thrasher Research Fund

1. Study Identification

Unique Protocol Identification Number

NCT00840983

Brief Title

Effects of Delayed Cord Clamping in Very Low Birth Weight Infants

Official Title

Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

August 2003 (undefined)

Primary Completion Date

November 2005 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rhode Island

Collaborators

National Institute of Nursing Research (NINR), Thrasher Research Fund

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.

Detailed Description

When cord clamping is delayed at birth or the cord is milked, infants receive a placental transfusion of 10-15 mL/kg during the first few minutes of life. This additional blood improves hemodynamic stability and may reduce the risk of intraventricular hemorrhage (IVH) and the vulnerability of infants to inflammatory processes. This blood also contains stem cells that are important in repairing tissue and building immunocompetence. The current randomized controlled trial prospectively tested the effects of DCC for 30-45 seconds followed by 1 cord milking with the aim of confirming our prior work and providing long-term follow-up. Our a priori hypotheses were that DCC would reduce the incidence of IVH, LOS, and result in better motor function at 18-22 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intraventricular Hemorrhage, Late Onset Neonatal Sepsis, Motor Skills Disorders

Keywords

delayed cord clamping, very low birthweight infant, bronchopulmonary dysplasia, intraventricular hemorrhage, motor function

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1-Immediate Cord Clamping

Arm Type

No Intervention

Arm Description

infants received the routine care of immediate clamping of the umbilical cord

Arm Title

2-Delayed Cord Clamping

Arm Type

Experimental

Arm Description

after birth, cord clamping was delayed 30 to 45 seconds while infant was held lower than the level of the placenta.

Intervention Type

Procedure

Intervention Name(s)

delayed cord clamping

Other Intervention Name(s)

cord clamping time

Intervention Description

cord clamping was delayed for 30 to 45 seconds and infant was held lower than the level of the placenta

Primary Outcome Measure Information:

Title

VLBW infants in the delayed clamped group will have less chronic lung disease at 36 weeks postmenstrual age compared to VLBW infants in the immediate cord clamped grouped

Time Frame

36 wks postmenstrual age

Title

VLBW infants in the delayed clamped group will have fewer incidences of suspected necrotizing enterocolitis during the NICU stay when compared with VLBW infants in the immediate cord clamped group

Time Frame

Hospital discharge

Title

VLBW infants in the delayed clamped group will have better motor function by 6 to corrected age when compared with VLBW infants in the immediate cord clamped group

Time Frame

7 months corrected age

Secondary Outcome Measure Information:

Title

Infants in the delayed cord clamping group will have less IVH than infants in the immediate clamping group

Time Frame

NICU stay

Title

Infants in the delayed clamping group will hvae less late onset sepsis than infants in the immediate clamping group.

Time Frame

NICU Stay

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women pregnant with gestation 24 to 31.6 weeks of singleton pregnancy by obstetrical evaluation Obstetrician's approval of enrollment into study Parental consent Any mode of birth will be included Exclusion Criteria: Obstetrician's refusal to enroll infants Parental refusal for consent Prenatally-diagnosed major congenital anomalies [or multiple gestations] Intent to withhold or withdraw care Severe or multiple maternal illnesses, frank vaginal bleeding, placenta abruption or previa Mothers who are institutionalized or psychotic

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Judith S Mercer, PhD, CNM

Organizational Affiliation

University of Rhode Island

Official's Role

Principal Investigator

Facility Information:

Facility Name

Women & Infants Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16585320

Citation

Mercer JS, Vohr BR, McGrath MM, Padbury JF, Wallach M, Oh W. Delayed cord clamping in very preterm infants reduces the incidence of intraventricular hemorrhage and late-onset sepsis: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):1235-42. doi: 10.1542/peds.2005-1706.

Results Reference

background

PubMed Identifier

19847185

Citation

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.

Results Reference

background

PubMed Identifier

26547399

Citation

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.

Results Reference

result

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Effects of Delayed Cord Clamping in Very Low Birth Weight Infants

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