Clinical trial NCT01426698: 18 Month Follow Up of Preterm Infants Enrolled in the Cord Clamping Study
Official title: 18 Month Follow Up of Preterm Infants Enrolled in the Cord Clamping Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Developmental Delay
Keywords: delayed cord clamping
developmental delay
Lead sponsor: University of Rhode Island
Sponsor class: OTHER
Collaborators: name: Women and Infants Hospital of Rhode Island
First posted: 2011-08-31
Enrollment: 208
Sex: ALL
Minimum age (years): 24
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: The current obstetrical practice at birth in the United States is that the umbilical cord of the very low birth weight (VLBW) infant is clamped immediately. When immediate cord clamping occurs, up to 50% of the fetal-placental blood volume may be left in the placenta acutely increasing vulnerability to hypovolemia (low blood volume). In the investigators previous randomized control trial, it was found that infants who received a simple delay in umbilical cord clamping for 30-45 seconds experienced significantly lower incidence of bleeding in the brain and fewer systemic infections throughout the Neonatal Intensive Care Unit (NICU) stay and had higher scores on muscular control and function at 7 months corrected age. In the investigators current Phase 2 randomized controlled trial, examines the motor functioning of infants randomized to immediate cord clamping (ICC) or delayed cord clamping (DCC) at 7 months corrected age (age based on due date and not the pre-term birth rate).

Our objective for this new grant from the Thrasher Foundation is to examine the differences in the long-term effects of ICC vs. DCC on developmental outcomes of our study infants at 18-22 months corrected age. The investigators hypothesis is that the positive effects of DCC, less bleeding in the brain and less infection, may also result in better motor and mental functioning at 18-22 months corrected age. Differentiation between cognitive and motor function is more obvious in the developing toddler than in younger infants. The diagnosis of cerebral palsy becomes more definitive with age and cognitive skills such as expressive and receptive language continue to emerge.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Motor function
timeFrame: 18-22 months
Secondary outcomes:
measure: Mental Functioning
timeFrame: 18 to 22 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Women and Infants Hospital of Rhode Island
name: Judith S Mercer, PhD, CNM
role: PRINCIPAL_INVESTIGATOR
References:
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: 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.
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.