18 Month Follow Up of Preterm Infants Enrolled in the Cord Clamping Study (18mo)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Developmental Delay |
Procedure: delayed cord clamping |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | 18 Month Follow Up of Preterm Infants Enrolled in the Cord Clamping Study |
- Motor function [ Time Frame: 18-22 months ] [ Designated as safety issue: Yes ]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.
- Mental Functioning [ Time Frame: 18 to 22 months ] [ Designated as safety issue: Yes ]Very low birth weight infants in the delayed cord-clamping group will have better mental functions at 18-22 months corrected age when compared with VLBW infants in the ICC group.
| Estimated Enrollment: | 212 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Immediate cord clamping
Infants in this arm will have had immediate cord clamping at birth
|
Procedure: delayed cord clamping
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.
Other Name: DCC
|
|
Experimental: Delayed Cord Clamping
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
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.
Other Name: DCC
|
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| Ages Eligible for Study: | 24 Weeks to 31 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Rhode Island | |
| Women & Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| Principal Investigator: | Judith S Mercer, PhD, CNM | Women and Infants Hospital of Rhode Island |
More Information
Publications:
| Responsible Party: | Judith S Mercer, Clinical Professor, University of Rhode Island |
| ClinicalTrials.gov Identifier: | NCT01426698 History of Changes |
| Other Study ID Numbers: | Mercer - 9625 |
| Study First Received: | August 19, 2011 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Rhode Island:
|
delayed cord clamping developmental delay |
ClinicalTrials.gov processed this record on June 18, 2013