Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants

NCT04413097 | Active Not Recruiting DMC

• 2 other identifiers: DOXIE5R03HD105224-02
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

Brief Summary

This study is being conducted to compare the incidence of preterm infants (up to 28+6 weeks GA) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life (MOL) given mask CPAP/PPV with an FiO2 of 1.0 during DCC for 90 seconds (HI Group) to infants given mask CPAP/PPV with an FiO2 of .30 during DCC for 90 seconds (LO Group).

Conditions

IVH- Intraventricular Hemorrhage; Extreme Prematurity; Hypoxia Neonatal; Hyperoxia; Respiratory Insufficiency

Keywords

Delayed Cord Clamping; IVH- Intraventricular Hemorrhage; Hyperoxia in Neonates; Hypoxia Neonatal; Continuous Positive Airway Pressure (CPAP)

Outcome Measures

Primary Outcomes (1)

• Feasibility of administration of oxygen during delayed cord clamping and it's impact on the incidence of preterm infants (up to 28 +6 weeks) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life

  To assess the feasibility and compare the incidence of preterm infants (up to 28+6 weeks GA) who achieve a peripheral oxygen saturation of 80 percent by 5 MOL given mask CPAP/PPV with an FiO2 of 1.0 during DCC for 90 seconds (HI Group) to infants given mask CPAP/PPV with an FiO2 of .30 during DCC for 90 seconds (LO Group).

  by 5 minutes of life

Secondary Outcomes (4)

• All Grade IVH

  Through study completion at hospital discharge, up to 6 months corrected gestational age (CGA)

• Frequency of Grade III and IV intraventricular hemorrhage

  Through study completion at hospital discharge, up to 6 months corrected gestational age (CGA)

• Resuscitation interventions

  In the first 10 minutes of life

• Changes in heart rate (BPM) in the first 10 minutes of life

  In the first 10 minutes of life

Other Outcomes (41)

• Changes in Inspired fractional oxygen (FiO2)

  In the first 10 minutes of life

• Duration of Hypoxia

  The first 10 minutes of life in the delivery room

• Duration of Hyperoxia

  The first 10 minutes of life in the delivery room

Study Arms (2)

DCC and Low Oxygen Concentration

ACTIVE COMPARATOR

During 90 seconds of delayed cord clamping, the infant will receive gentle stimulation and start CPAP by 30 seconds of life at an FiO2 .30, with CPAP of 5 cmH20. If the infant is apneic or there is no Pedicap color change the team will begin positive pressure ventilation (starting PIP of 20 cmH20) by 60 seconds of life. The infant will remain on this support up until the umbilical cord is clamped at 90 seconds or greater. Once the cord is clamped the infant resuscitation will continue according to unit protocol.

Procedure: Delayed Cord Clamping with Low Oxygen concentration

DCC and High Oxygen Concentration

EXPERIMENTAL

During 90 seconds of delayed cord clamping, the infant will receive gentle stimulation and start CPAP by 30 seconds of life at an FiO2 1.0, with CPAP of 5 cmH20. If the infant is apneic or there is no Pedicap color change the team will begin positive pressure ventilation (starting PIP of 20 cmH20) by 60 seconds of life. The infant will remain on this support up until the umbilical cord is clamped at 90 seconds or greater. Once the cord is clamped the infant resuscitation will continue according to unit protocol.

Procedure: Delayed Cord Clamping with High Oxygen concentration

Interventions

Delayed Cord Clamping with Low Oxygen concentration PROCEDURE

During delayed umbilical cord clamping of 90 seconds, breathing assistance with CPAP/PPV and low oxygen concentration (FiO2 0.30) will be provided.

Also known as: DCC with Low Oxygen concentration, DCC LO group

DCC and Low Oxygen Concentration

Delayed Cord Clamping with High Oxygen concentration PROCEDURE

During delayed umbilical cord clamping of 90 seconds, breathing assistance with CPAP/PPV and high oxygen concentration (FiO2 1.0) will be provided.

Also known as: DCC with High Oxygen concentration, DCC HI group

DCC and High Oxygen Concentration

Eligibility Criteria

• Age: 22 Weeks - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• up to 28+6 weeks Gestational age
• Single and Multiple pregnancy
• All modes of delivery (vaginally or caesarean section)

You may not qualify if:

• Parents decline consent
• Congenital anomalies of the newborn
• Bleeding Accreta
• Monochorionic multiples with evidence of TTTS
• Fetal or maternal risk (i.e. compromise)
• Preterm Premature Rupture of Membranes prior to 20 weeks gestation
• Parents request no resuscitation

Sponsors & Collaborators

• Sharp HealthCare: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Sharp Mary Birch Hospital for Women & Newborns: collaborator

Study Sites (3)

University of California Davis

Davis, California, 95817, United States

Location

University of California San Diego Jacobs Medical Center

San Diego, California, 92037, United States

Location

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

Related Publications (60)

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  BACKGROUND

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  BACKGROUND

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  PMID: 40690234 DERIVED

MeSH Terms

Conditions

Asphyxia Neonatorum; Hyperoxia; Respiratory Insufficiency

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Anup Katheria, MD

  Sharp HealthCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Once consent is obtained and the research staff is notified of a subject's impending birth, our research team member will open a randomization card and set the oxygen blender on the special bed to either an FiO2 of .30 or 1.0 and cover the blender. The research team member will not be involved in the clinical care for the infant and will blind the clinical care team from the randomized assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neonatal Research Institute

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 2, 2020
• Study Start: November 17, 2021
• Primary Completion: May 19, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 2 years after primary publication
• Access Criteria: An archived dataset with documentation will be made available for additional users by outside investigators, in collaboration with the study investigators. We will work with NICHD program staff to develop a broad data sharing plan over time.

Locations

US (3)