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

Shanghai Jiao Tong University

Status: Completed

Conditions: Anemia

Treatments: Procedure: umbilical cord clamping immediately; Procedure: umbilical cord milking

Study type: Interventional

Funder types: Other

Identifiers

NCT03023917

XH-16-050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 284 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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284 participants in 2 patient groups

umbilical cord clamping immediately

Active Comparator group

Description:

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).

Treatment:

Procedure: umbilical cord clamping immediately

umbilical cord milking

Experimental group

Description:

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

Treatment:

Procedure: umbilical cord milking