Clinical trial NCT00840983: 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
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: University of Rhode Island
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Thrasher Research Fund
First posted: 2009-02-11
Enrollment: 72
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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
timeFrame: 36 wks postmenstrual age
measure: 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
timeFrame: Hospital discharge
measure: 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
timeFrame: 7 months corrected age
Secondary outcomes:
measure: Infants in the delayed cord clamping group will have less IVH than infants in the immediate clamping group
timeFrame: NICU stay
measure: Infants in the delayed clamping group will hvae less late onset sepsis than infants in the immediate clamping group.
timeFrame: NICU Stay
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital
state: Rhode Island
Study officials:
affiliation: University of Rhode Island
name: Judith S Mercer, PhD, CNM
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.