Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up

Not Applicable

Recruiting

• Conditions: Hypoxic-Ischemic Encephalopathy; Birth Asphyxia
• Interventions: Other: Umbilical Cord Milking

• Registration Number: NCT03682042
• Lead Sponsor: Nemours Children's Clinic

Brief Summary

An extension of the CORDMILK trial, the CORDMILK follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were non-vigorous at birth and received umbilical cord milking (UCM) or early cord clamping (ECC).

Detailed Description

The CORDMILK Follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were non-vigorous at birth and enrolled in the CORDMILK trial. The difference in survival and neurodevelopmental impairment in infants who received UCM and ECC will be assessed using standardized neurological and developmental assessment tools at 22-26 months of age.

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-24
• Study Start: 2022-10-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08
• Primary Completion: 2027-04-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3442

Inclusion Criteria

• Enrolled in CORDMILK trial
• Non-vigorous at birth

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Umbilical Cord Milking	Umbilical Cord Milking	At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 10-15 seconds.

Primary Outcome Measures

Name	Time	Method
Neurodevelopmental Outcome at 2 Years of Age	22-26 months	Neurodevelopmental assessment will be performed by the trained and experienced examiner who will be blinded to the interventions.; Severe neurodevelopmental impairment will be defined having at least one of the following: BSID (IV) composite cognitive score \<70, GMFCS level 3-5, blindness (vision \<20/200), or hearing impairment requiring hearing aids/cochlear implant. Moderate neurodevelopmental impairment will be defined as having a cognitive composite score 70-84, GMFCS level 2, unilateral blindness (vision/20/200 in only one eye), or hearing impairment with no amplification/cochlear implant.

Secondary Outcome Measures

Name	Time	Method
Neurodevelopmental Outcome at 1 Year of Age	10-14 months	Neurodevelopmental assessment will be performed by the trained and experienced examiner who will be blinded to the intervention using the Developmental Assessment Scales for Indian Infants (DASII). DAASI provides developmental motor quotient (DMoQ), developmental mental quotient (DMeQ), and composite developmental quotient (DQ). With a mean DQ of 100 and standard deviation (SD) of 15, 1SD and 2SD below mean correspond to DQ of 85 and 70, respectively. A DMoQ, DMeQ or DQ score of \<70 (2SD) is considered as neurodevelopmental impairment.

Trial Locations

Locations (9)

KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College; 🇮🇳 Belgaum, Karnataka, India

Indira Gandhi Government Medical College & Hospital; 🇮🇳 Nagpur, Maharashtra, India

Government Medical College; 🇮🇳 Chandrapur, MS, India

Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital; 🇮🇳 Pune, Maharashtra, India

Daga Memorial Woman and Children Hospital; 🇮🇳 Nagpur, MS, India

Government Medical College and Hospital; 🇮🇳 Nagpur, MS, India

All India Institute of Medical Science; 🇮🇳 Nagpur, MS, India

Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital; 🇮🇳 Wardha, MS, India

Sawai Man Singh (SMS) Medical College; 🇮🇳 Jaipur, Rajasthan, India