Effects of Delayed Cord Clamping in Very Low Birth Weight Infants

NCT00840983 | Completed Phase 1 DMC

• 2 other identifiers: Mercer-K23-03R01NR010015-01A2
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

  36 wks postmenstrual age

• 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

  Hospital discharge

• 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

  7 months corrected age

Secondary Outcomes (2)

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

  NICU stay

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

  NICU Stay

Study Arms (2)

1-Immediate Cord Clamping

NO INTERVENTION

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

2-Delayed Cord Clamping

EXPERIMENTAL

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

Procedure: delayed cord clamping

Interventions

delayed cord clamping PROCEDURE

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

Also known as: cord clamping time

2-Delayed Cord Clamping

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rhode Island: lead
• National Institute of Nursing Research (NINR): collaborator
• Thrasher Research Fund: collaborator

Study Sites (1)

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Related Publications (3)

• 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.

  PMID: 16585320 BACKGROUND

• 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: 19847185 BACKGROUND

• 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: 26547399 RESULT

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Enterocolitis, Necrotizing; Neonatal Sepsis; Motor Skills Disorders

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Judith S Mercer, PhD, CNM

  University of Rhode Island

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emerita

Study Record Dates

• First Submitted: February 10, 2009
• First Posted: February 11, 2009
• Study Start: August 1, 2003
• Primary Completion: November 1, 2005
• Study Completion: December 1, 2006
• Last Updated: November 30, 2015

Record last verified: 2015-11

Locations

US (1)