- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03023917
The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in Preterms
The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in preterms--a Multi-center Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Anemia is a significant problem for pre-term infants and a major risk factor for preterm babies mortality and morbidity in neonatal intensive care unit(NICU). the majority of pre-term babies will require one or more blood transfusions during in NICU. Blood transfusion is a safe procedure but like all therapeutic interventions has risks associated with it and effort is made to reduce the number of transfusions that infants require during their stay on the neonatal unit.
Delayed cord clamping has a beneficial effect on prevention of anemia in later infancy because of increased iron stores at birth. However there are controversies in incorporating delayed cord clamping practice in the management of third stage of labour globally. Concerning about the need for urgent resuscitation and temperature management, attendants encouraged to clamp the umbilical cord immediately so that post-natal resuscitation and care can start as soon as possible.However,umbilical cord milking allows for swift intervention and resuscitation and attention to thermal care and should take less than 10 seconds to complete.
The specific aim of this study is to investigate the effects of umbilical cord milking on preventing and decreasing anemia in very pre-term infants.
Primary Outcomes:
Hemoglobin (Hb), Hematocrit (Hct) and serum iron levels at birth, at 1 week,at 2 weeks of age.
Secondary Outcomes:
- Hemoglobin,hematocrit levels at 6 months of age.
- Anemia at 1 week of life and 6 months follow-up, defined as hemoglobin levels below the respective cutoffs.
- number of blood transfusions until 3 months corrected gestational age (CGA).
- short term clinical profile of neonates like jaundice, polycythemia etc.
- preterm infant complications such as lung function as assessed by oxygen dependency at 36 weeks corrected gestational age (CGA), and cardiovascular function as assessed by the need for volume expansion, inotropes, or clinically suspected patent ductus arteriosus(PDA )requiring intervention prior to discharge home,incidence of intraventricular hemorrhage and late-onset sepsis,etc.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200092
- Xinhua Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women in labour or with a plan for delivery at a gestational age less than 34 weeks gestation.
- Singleton pregnancy
- informed consent was obtained from the parent
Exclusion Criteria:
- Multiple gestation
- Diagnosis of any of the following in the current pregnancy: hemorrhage requiring clinic/hospital admission, placental abnormalities, fetal anomalies, Down's syndrome of the fetus,anemia
- Diagnosis of pre-eclampsia or eclampsia in current or previous pregnancies
- Diagnosis at any time for the mother of any of the following: serious Diabetes, serious hypertension, chronic renal disease
- Infant with major congenital malformation
- Infant with blood disease
- Unwilling to return for follow-up study visits at the hospital
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: umbilical cord clamping immediately
Umbilical cord was clamped immediately, or as close as possible, after delivery of the infant's shoulders.
(This was standard practice in the study hospital, thus it served as the "control" group).
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umbilical cord was cut immediately after birth
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Experimental: umbilical cord milking
preterm baby were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord.
The milking speed was about 25cm/2 seconds
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Infants were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord.
The milking speed was about 25cm/2 seconds
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
concentrations of Hemoglobin (Hb)
Time Frame: 48 hours after birth
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48 hours after birth
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concentrations of Hematocrit(Hct)
Time Frame: 48 hours after birth
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48 hours after birth
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serum ferritin level
Time Frame: 48 hours after birth
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48 hours after birth
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hyperbilirubinemia requiring phototherapy
Time Frame: during first 2 weeks of age
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Hyperbilirubinemia requiring phototherapy (as per routine unit practice)
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during first 2 weeks of age
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incidence and numbers of blood transfusions
Time Frame: until 3 months corrected gestational age
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until 3 months corrected gestational age
|
|
Length of admission
Time Frame: Birth to discharge, expected average of 30 days
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Birth to discharge, expected average of 30 days
|
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complication
Time Frame: Birth to discharge, expected average of 30 days
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composite of bronchopulmonary dysplasia , Necrotizing Enterocolitis , grade 3 or 4 intraventricular hemorrhage or periventricular leukomalacia , or death prior to discharge home
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Birth to discharge, expected average of 30 days
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: guangyu chen, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XH-16-050
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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