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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Procedure: umbilical cord clamping immediately; Procedure: 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 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: Interventional
• Enrollment (Actual): 284
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Xinhua hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

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).	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
concentrations of Hemoglobin (Hb)	48 hours after birth
concentrations of Hematocrit(Hct)	48 hours after birth
serum ferritin level	48 hours after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyperbilirubinemia requiring phototherapy	Hyperbilirubinemia requiring phototherapy (as per routine unit practice)	during first 2 weeks of age
incidence and numbers of blood transfusions		until 3 months corrected gestational age
Length of admission		Birth to discharge, expected average of 30 days
complication	composite of bronchopulmonary dysplasia , Necrotizing Enterocolitis , grade 3 or 4 intraventricular hemorrhage or periventricular leukomalacia , or death prior to discharge home	Birth to discharge, expected average of 30 days

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborators: Shanghai First Maternity and Infant Hospital; Yangpu District Central Hospital Affiliated to Tongji University
• Investigators: Study Chair: guangyu chen, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (Estimate): January 18, 2017

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 24, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: umbilical cord milking;anemia;placental transfusion
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: XH-16-050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No