Bronchopulmonary Dysplasia Clinical Trial
Official title:
Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants
Verified date | November 2015 |
Source | University of Rhode Island |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | December 2006 |
Est. primary completion date | November 2005 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Women & Infants Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
University of Rhode Island | National Institute of Nursing Research (NINR), Thrasher Research Fund |
United States,
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.201 — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Primary | 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 | No | |
Primary | 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 | No | |
Secondary | Infants in the delayed cord clamping group will have less IVH than infants in the immediate clamping group | NICU stay | No | |
Secondary | Infants in the delayed clamping group will hvae less late onset sepsis than infants in the immediate clamping group. | NICU Stay | No |
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