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Completed

NCT Number: NCT03023917

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Umbilical Cord Milking

Procedure

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

umbilical cord clamping immediately

Procedure

umbilical cord was cut immediately after birth

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Shanghai First Maternity and Infant Hospital
  • Yangpu District Central Hospital Affiliated to Tongji University

Registry information

Official study title

The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in preterms--a Multi-center Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2017
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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