Effects of Delayed Cord Clamping in Very Low Birth Weight Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants

Conditions
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Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intraventricular Hemorrhage, Late Onset Neonatal Sepsis, Motor Skills Disorders

Intervention / Treatment
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* Procedure: delayed cord clamping


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1-Immediate Cord Clamping<br>infants received the routine care of immediate clamping of the umbilical cord | |
| Experimental: 2-Delayed Cord Clamping<br>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<br>* cord clamping was delayed for 30 to 45 seconds and infant was held lower than the level of the placenta<br>* Other names: cord clamping time;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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delayed cord clamping, very low birthweight infant, bronchopulmonary dysplasia, intraventricular hemorrhage, motor function