Clinical trial NCT03023917: The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in Preterms
Official title: The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in preterms--a Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: umbilical cord milking;anemia;placental transfusion
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai First Maternity and Infant Hospital
name: Yangpu District Central Hospital Affiliated to Tongji University
First posted: 2017-01-18
Enrollment: 284
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: concentrations of Hemoglobin (Hb)
timeFrame: 48 hours after birth
measure: concentrations of Hematocrit(Hct)
timeFrame: 48 hours after birth
measure: serum ferritin level
timeFrame: 48 hours after birth
Secondary outcomes:
measure: Hyperbilirubinemia requiring phototherapy
timeFrame: during first 2 weeks of age
measure: incidence and numbers of blood transfusions
timeFrame: until 3 months corrected gestational age
measure: Length of admission
timeFrame: Birth to discharge, expected average of 30 days
measure: complication
timeFrame: Birth to discharge, expected average of 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: guangyu chen
role: STUDY_CHAIR
References: