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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

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.

Condition or disease Intervention/treatment Phase
Anemia Procedure: umbilical cord milking Procedure: umbilical cord clamping immediately Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in preterms--a Multi-center Randomized Controlled Trial
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

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).
Procedure: umbilical cord clamping immediately
umbilical cord was cut immediately after birth

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
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




Primary Outcome Measures :
  1. concentrations of Hemoglobin (Hb) [ Time Frame: 48 hours after birth ]
  2. concentrations of Hematocrit(Hct) [ Time Frame: 48 hours after birth ]
  3. serum ferritin level [ Time Frame: 48 hours after birth ]

Secondary Outcome Measures :
  1. Hyperbilirubinemia requiring phototherapy [ Time Frame: during first 2 weeks of age ]
    Hyperbilirubinemia requiring phototherapy (as per routine unit practice)

  2. incidence and numbers of blood transfusions [ Time Frame: until 3 months corrected gestational age ]
  3. Length of admission [ Time Frame: Birth to discharge, expected average of 30 days ]
  4. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023917


Contacts
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Contact: Lijuan XIE, director 021-25078999 ext 8395 xlj68115@sina.com
Contact: hongping xia 021-25078999 ext 8395 xlj68115@sina.com

Locations
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China, Shanghai
Xinhua Hospital Recruiting
Shanghai, Shanghai, China, 200092
Contact: lijuan xie    021-25078999 ext 8395    xlj68115@sina.com   
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai First Maternity and Infant Hospital
Yangpu District Central Hospital Affiliated to Tongji University
Investigators
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Study Chair: guangyu chen Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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Responsible Party: Lijuan Xie, Principal Investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03023917     History of Changes
Other Study ID Numbers: XH-16-050
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lijuan Xie, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
jaundice,complication

Additional relevant MeSH terms:
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Anemia
Hematologic Diseases