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

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anemia

• NCT number: NCT03023917
• Study type: Interventional
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Status: Completed
• Phase: N/A
• Start date: June 30, 2017
• Completion date: December 31, 2019