NCT03023917

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Anemia

Interventions

Type	Name	Description
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
PROCEDURE	umbilical cord clamping immediately	umbilical cord was cut immediately after birth

Timeline

• Start date: 2017-06-30
• Primary completion: 2019-08-31
• Completion: 2019-12-31
• First posted: 2017-01-18
• Last updated: 2020-10-27

Locations

1 site across 1 country: China