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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03023917
• Other study ID #: XH-16-050
• Status: Completed
• Phase: N/A
• Start date: June 30, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: December 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

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
• umbilical cord clamping immediately
umbilical cord was cut immediately after birth

Locations

Country	Name	City	State
China	Xinhua Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai First Maternity and Infant Hospital, Yangpu District Central Hospital Affiliated to Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concentrations of Hemoglobin (Hb)		48 hours after birth
Primary	concentrations of Hematocrit(Hct)		48 hours after birth
Primary	serum ferritin level		48 hours after birth
Secondary	Hyperbilirubinemia requiring phototherapy	Hyperbilirubinemia requiring phototherapy (as per routine unit practice)	during first 2 weeks of age
Secondary	incidence and numbers of blood transfusions		until 3 months corrected gestational age
Secondary	Length of admission		Birth to discharge, expected average of 30 days
Secondary	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