Delayed Clamping and Milking the Umbilical Cord in Preterm Infants
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|ClinicalTrials.gov Identifier: NCT02092103|
Recruitment Status : Recruiting
First Posted : March 19, 2014
Last Update Posted : May 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Premature Birth||Procedure: Cord Milking||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Delayed Clamping and Milking the Umbilical Cord Prior to Clamping in Preterm Infants and the Effect of Neonatal Outcomes|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
No Intervention: Delayed Clamping
The American Congress of Obstetricians and Gynecologists (ACOG) recommends delayed cord clamping for preterm infants. Infants randomized to this group will follow the protocol below:
Experimental: Cord Milking
Infants randomized to the cord milking group will follow the protocol below:
Procedure: Cord Milking
See description in cord milking arm.
- Hemoglobin and Hematocrit values (H/H) in NICU [ Time Frame: NICU admission to discharge, expected average of 50 days ]All H/H values in the neonatal intensive care unit (NICU) will be recorded.
- Neonatal transfusions [ Time Frame: Birth to discharge, expected average of 50 days ]The incidence of transfusions between the two groups will be compared.
- Necrotizing enterocolitis [ Time Frame: Birth to discharge, expected average of 50 days ]The incidence of necrotizing enterocolitis between the two groups will be compared.
- Intraventricular hemorrhage [ Time Frame: Birth to discharge, expected average of 50 days ]The incidence of intraventricular hemorrhage between the two groups will be compared.
- Length of stay [ Time Frame: Birth to discharge, expected average of 50 days ]The length of NICU stay between the two arms will be compared.
- Survival to discharge [ Time Frame: Birth to discharge, expected average of 50 days ]The rate of infant survival until discharge will be recorded for both groups.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092103
|Contact: Kathleen Smith, MD PhDemail@example.com|
|Contact: Stephanie Manolis, DOfirstname.lastname@example.org|
|United States, Ohio|
|Good Samaritan TriHealth Hospital||Recruiting|
|Cincinnati, Ohio, United States, 45220|
|Contact: Ganga Devaiah, MS 513-862-2341 email@example.com|
|Principal Investigator:||Kathleen Smith, MD PhD||TriHealth Inc.|