18 Month Follow Up of Preterm Infants Enrolled in the Cord Clamping Study (18mo)

University of Rhode Island

Status and phase: Completed; Phase 2

Conditions: Developmental Delay

Treatments: Procedure: delayed cord clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT01426698

Mercer - 9625

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 patients

Sex: All

Ages: 24 to 31 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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208 participants in 2 patient groups

Immediate cord clamping

Active Comparator group

Description:

Infants in this arm will have had immediate cord clamping at birth which is routine care at the hospital

Treatment:

Procedure: delayed cord clamping

Delayed Cord Clamping

Experimental group

Description:

Intervention: 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.

Treatment:

Procedure: delayed cord clamping