NCT03621956

Brief Summary

3 clinical sites enrolling in the primary MINVI trial (NCT03631940) will collect Near Infrared Spectroscopy (NIRS) data in the first 10 minutes of life on a subset of 200 non-vigorous term and near-term infants enrolled in the trial.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

January 7, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 8, 2024

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

2.4 years

First QC Date

August 6, 2018

Results QC Date

January 2, 2024

Last Update Submit

July 2, 2024

Conditions

Birth Asphyxia With Neurologic Involvement

Keywords

Near-Infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

  • StO2 in the First 10 Minutes of Life

    Cerebral oxygenation derived from skeletal muscle oxygen saturation (StO2) measured by near-infrared spectroscopy (NIRS). Once the newborn is delivered, receives the intervention (UCM or ECC), and is stabilized during resuscitation, a NIRS sensor (Fore-Sight, CAS Medical, Branford, CT) will be placed on the right forehead within 10 minutes of the newborn being placed on the resuscitation bed.

    birth to 10 minutes of life

Secondary Outcomes (1)

  • Heart Rate at 10 Minutes

    Birth to 10 minutes of life

Study Arms (2)

Umbilical Cord Milking

ACTIVE COMPARATOR

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 15-20 seconds.

Procedure: Umbilical Cord Milking

Early Cord Clamping

ACTIVE COMPARATOR

The umbilical cord is clamped within 30 seconds of delivery.

Procedure: Early Cord Clamping

Interventions

Umbilical Cord MilkingPROCEDURE

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 15-20 seconds.

Umbilical Cord Milking
Early Cord ClampingPROCEDURE

The umbilical cord is clamped within 30 seconds of delivery.

Early Cord Clamping

Eligibility Criteria

Age35 Weeks - 42 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Non-vigorous newborns born between 35-42 weeks gestation
  • Born at NIRS Sub-study site

You may not qualify if:

  • Known major congenital or chromosomal anomalies of newborn
  • Known cardiac defects other than small ASD, VSD and PDA
  • Complete placental abruption/cutting through the placenta at time of delivery
  • Monochorionic multiples
  • Cord Avulsion
  • Presence of non-reducible nuchal cord
  • Perinatal providers unaware of the protocol
  • Incomplete delivery data Infants born in extremis, for whom additional treatment will not be offered

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sharp Grossmont Hospial

San Diego, California, 91942, United States

Location

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

Governors of University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

Related Publications (1)

  • Katheria AC, Law BHY, Poeltler D, Rich W, Ines F, Schmolzer GM, Lakshminrusimha S. Cardiac and cerebral hemodynamics with umbilical cord milking compared with early cord clamping: A randomized cluster crossover trial. Early Hum Dev. 2023 Mar;177-178:105728. doi: 10.1016/j.earlhumdev.2023.105728. Epub 2023 Feb 14.

    PMID: 36827750DERIVED

MeSH Terms

Interventions

Umbilical Cord Clamping

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Anup Katheria, M.D.
Organization
Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns
anup.katheria@sharp.com
858-939-4170

Study Officials

  • Anup Katheria, MD

    Sharp Mary Birch Hospital for Women & Newborns

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Neonatal Research Institute

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 9, 2018

Study Start

January 7, 2019

Primary Completion

June 1, 2021

Study Completion

December 26, 2022

Last Updated

July 8, 2024

Results First Posted

July 8, 2024

Record last verified: 2024-07

Locations

US(2)CA(1)