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The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in Preterms

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ClinicalTrials.gov Identifier: NCT03023917
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : October 6, 2017
Sponsor:
Collaborators:
Shanghai First Maternity and Infant Hospital
Yangpu District Central Hospital Affiliated to Tongji University
Information provided by (Responsible Party):
Lijuan Xie, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Tracking Information
First Submitted Date  ICMJE January 3, 2017
First Posted Date  ICMJE January 18, 2017
Last Update Posted Date October 6, 2017
Actual Study Start Date  ICMJE June 30, 2017
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • concentrations of Hemoglobin (Hb) [ Time Frame: 48 hours after birth ]
  • concentrations of Hematocrit(Hct) [ Time Frame: 48 hours after birth ]
  • serum ferritin level [ Time Frame: 48 hours after birth ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03023917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • Hyperbilirubinemia requiring phototherapy [ Time Frame: during first 2 weeks of age ]
    Hyperbilirubinemia requiring phototherapy (as per routine unit practice)
  • incidence and numbers of blood transfusions [ Time Frame: until 3 months corrected gestational age ]
  • Length of admission [ Time Frame: Birth to discharge, expected average of 30 days ]
  • complication [ Time Frame: Birth to discharge, expected average of 30 days ]
    composite of bronchopulmonary dysplasia , Necrotizing Enterocolitis , grade 3 or 4 intraventricular hemorrhage or periventricular leukomalacia , or death prior to discharge home
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in Preterms
Official Title  ICMJE The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in preterms--a Multi-center Randomized Controlled Trial
Brief Summary The overall objective of the present study is to examine the effects of umbilical cord milking at birth in preterm infants to prevent and decrease anemia using a multi-center prospective randomized controlled trial comparing immediate cord clamping (standard at present) with umbilical cord milking.
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:

To study the effect of umbilical cord milking on hemoglobin (Hb), Hematocrit (Hct)and ferritin at birth, at seventh day and three months of age.

Secondary:

To study the effect of umbilical cord milking on short term clinical profile of neonates like jaundice, polycythemia etc.

To evaluate the number of blood transfusions until 3 months corrected gestational age (CGA), To assess 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Anemia
Intervention  ICMJE
  • Procedure: umbilical cord milking
    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
  • Procedure: umbilical cord clamping immediately
    umbilical cord was cut immediately after birth
Study Arms  ICMJE
  • 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).
    Intervention: Procedure: umbilical cord clamping immediately
  • 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
    Intervention: Procedure: umbilical cord milking
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 13, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lijuan XIE, director 021-25078999 ext 8395 xlj68115@sina.com
Contact: hongping xia 021-25078999 ext 8395 xlj68115@sina.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03023917
Other Study ID Numbers  ICMJE XH-16-050
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lijuan Xie, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study Sponsor  ICMJE Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators  ICMJE
  • Shanghai First Maternity and Infant Hospital
  • Yangpu District Central Hospital Affiliated to Tongji University
Investigators  ICMJE
Study Chair: guangyu chen Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
PRS Account Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP