Clinical trial NCT04413097: Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
Official title: Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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)
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Sharp Mary Birch Hospital for Women & Newborns
First posted: 2020-06-02
Enrollment: 140
Sex: ALL
Minimum age (years): 22
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Detailed description: Prenatal consent will be obtained on infant's with estimated gestational age up to 28+6 weeks. Shortly before delivery, infant's will be randomly assigned to receive either Low oxygen concentration (FiO2 .30) OR High oxygen concentration (FiO2 1.0) during 90 seconds of delayed cord clamping.

Randomization and intervention will remain blinded to the clinical care team during the entire study period. The research team member will open a randomization card when notified of a subject's impending birth, review the protocol with the obstetric provider performing the procedure, set-up the sterile stabilization bed, and note the time it takes from delivery until the clamping and cutting of the umbilical cord in both groups.

The research team member will set the oxygen blender as indicated by the randomization card and cover the blender to blind the FiO2 setting. The research team member will not be involved in the clinical care of the infant. The oxygen blender will be concealed from the clinical care team to ensure resuscitation maneuvers will not be biased.

Data will be submitted to the statistician, who will remain blinded to the intervention for the duration of the study.

At delivery, the infant will be placed on a platform that allows the infant to be close to the mother and the umbilical cord to remain intact for DCC. These beds are equipped with an oxygen blender, humidifier, t-piece resuscitator with mask, necessary to provide CPAP/PPV. At some centers the bed will be equipped with a radian warmer (Ceramotherm, Wyer GmbH, Germany) to maintain thermoregulation on the infant during delayed cord clamping.

If an infant is randomized to the DCC and Low Oxygen concentration (DCC LO group), the following procedure will ensue:

During delayed cord clamping, the infant will be gently stimulated by drying the infant with a sterile towel and provide CPAP by 30 seconds of life. During delayed cord clamping, breathing assistance with CPAP of 5 cm H20 and a FiO2 0.3 will be provided.

If an infant is randomized to the DCC and High Oxygen concentration (DCC HI group), the following procedure will ensue:

During delayed cord clamping, the infant will be gently stimulated by drying the infant with a sterile towel and provide CPAP by 30 seconds of life. During delayed cord clamping, breathing assistance with CPAP of 5 cm H20 and a FiO2 1.0 will be provided.

Patency of the airway in both groups will be assessed by a Colorimetric CO2 detector. Lack of color change will indicate that the airway is not patent (obstructed), the pressure is not sufficient to expand the lungs, there was excessive air leak, or there was no or inadequate pulmonary blood flow. If there is no color change, the neonatal provider will reposition and reattempt to open the airway, if no improvement they will initiate PPV (starting PIP of 20 cm H20) by 60 seconds of life. Cord clamping will occur at 90 seconds or greater and the infant will be transferred to a standard neonatal warmer and resuscitated per NRP guidelines.

Additionally, when available heart rate data will be collected using a non-invasive dry-electrode monitor, (NeoBeat, Laerdal Medical, Stavanger, Norway) and applied over the infant's chest or abdomen to provide continuous display of heart rate during 90 seconds of DCC.

Pulse oximetry, ECG sensors and Near-Infrared Spectroscopy (NIRS) sensors will be applied after cord clamping. The NIRS sensor will be placed on the infant's forehead. Cerebral StO2, SpO2, blood pressure (once in the NICU) and Heart rate will be recorded every two seconds and linked with other variables. These variables will continue to be recorded for the first 24 hours of life.

Blood sample will be collected at two different time points: Cord blood sample (T1: Cord blood collected after the cord is cut) and at 2 hours of life or NICU admission (T2). This is extra few drops of blood that is drawn from the baby for medical purposes (cord blood from cord gases and admission blood work up).

Samples will be tested for oxidized and reduced glutathione which are the most reliable and comprehensive biomarkers of oxidative stress.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: by 5 minutes of life
Secondary outcomes:
measure: All Grade IVH
timeFrame: Through study completion at hospital discharge, up to 6 months corrected gestational age (CGA)
measure: Frequency of Grade III and IV intraventricular hemorrhage
timeFrame: Through study completion at hospital discharge, up to 6 months corrected gestational age (CGA)
measure: Resuscitation interventions
timeFrame: In the first 10 minutes of life
measure: Changes in heart rate (BPM) in the first 10 minutes of life
timeFrame: In the first 10 minutes of life
Other outcomes:
measure: Changes in Inspired fractional oxygen (FiO2)
timeFrame: In the first 10 minutes of life
measure: Duration of Hypoxia
timeFrame: The first 10 minutes of life in the delivery room
measure: Duration of Hyperoxia
timeFrame: The first 10 minutes of life in the delivery room
measure: Changes in Mean airway pressure, MAP (cm H20)
timeFrame: In the first 10 minutes of life
measure: Duration of Positive Pressure Ventilation
timeFrame: The first 10 minutes of life in the delivery room
measure: Blood pressures in the first 24 hours of life
timeFrame: In the first 24 hours of life
measure: Cerebral tissue oxygenation in the first 24 hours of life
timeFrame: In the first 24 hours of life
measure: Average oxygen saturation in the first 5 minutes after birth
timeFrame: by 5 minutes of life
measure: Average Heart rate in the first 5 minutes after birth
timeFrame: by 5 minutes of life
measure: Intubation in the Delivery room or Neonatal Intensive Care Unit (NICU)
timeFrame: Birth through study completion at discharge, up to 6 months of corrected gestational age
measure: Lowest and Highest Hemoglobin and/or Hematocrit
timeFrame: First 24 hours of life
measure: Mean arterial blood pressure
timeFrame: First 24 hours of life
measure: Medication for Low Blood Pressure
timeFrame: First 24 hours of life
measure: CRIB-II (Clinical Risk Index for Babies)
timeFrame: First 12 hours of life
measure: Duration of mechanical ventilation and/or CPAP
timeFrame: Birth through study completion at discharge, up to 6 months of corrected gestational age
measure: Surfactant administration
timeFrame: Immediately after intervention through study completion at hospital discharge, up to 6 months of corrected gestational age
measure: Number of RBC Transfusions since birth
timeFrame: First 10 days after birth
measure: Patent Ductus Arteriosus requiring pharmacological or surgical treatment
timeFrame: Through study completion at discharge, up to 6 months of corrected gestational age
measure: Spontaneous Intestinal Perforation (SIP) requiring surgery or peritoneal drain
timeFrame: Through study completion at discharge, up to 6 months of corrected gestational age
measure: Necrotizing Enterocolitis (Modified Bell's stage 2-3)
timeFrame: Through study completion at discharge, up to 6 months of corrected gestational age
measure: Bronchopulmonary Dysplasia (mode of respiratory support administered at 36 weeks postmenstrual age; as defined and categorized in; Jensen, Dysart, Gantz, et al: Defining Bronchopulmonary Dysplasia) http://www.ncbi.nlm.nih.gov/pmc/articles/pmc6775872/
timeFrame: Hospital course until 36 weeks PMA
measure: Severe ROP (stage 3 or treated with laser or bevacizumab)
timeFrame: After the intervention through study completion at hospital discharge, up to 6 months of corrected gestational age
measure: Combined outcome of severe IVH and/or death
timeFrame: Through study completion at death or discharge, up to 6 months of corrected gestational age
measure: Death
timeFrame: Through study completion at death or discharge, up to 6 months of corrected gestational age
measure: SVC Flow
timeFrame: 6 hours of life
measure: RVO
timeFrame: 6 hours of life
measure: Left Ventricular Output
timeFrame: 6 hours of life
measure: Cognitive Composite Score
timeFrame: 24 months corrected age
measure: Language Composite Score
timeFrame: 24 months corrected age
measure: Motor Composite Score
timeFrame: 24 months corrected age
measure: Cerebral Palsy
timeFrame: 24 months corrected age
measure: Neurodevelopmental Outcome at 2 Years of Age
timeFrame: 22-26 months corrected age
measure: Pulsatility Index
timeFrame: 6 hours of life
measure: Resistive Index
timeFrame: 6 hours of life
measure: Changes in cerebral oxygenation saturation, StO2 (%)
timeFrame: In the first 10 minutes of life
measure: Changes in SpO2 (%) in the first 10 minutes of life
timeFrame: In the first 10 minutes of life
measure: Inhaled Nitric Oxide
timeFrame: Immediately after intervention through study completion at hospital discharge, up to 6 months of corrected gestational age
measure: Glutathione (GSH/GSSG ratio)
timeFrame: from birth up to NICU admission or in the first 2 hours of life
measure: Thermoregulation
timeFrame: from 5 minutes of life up to NICU admission in the first 2 hours of life
measure: Rate of Early Onset Sepsis
timeFrame: From birth up to 72 hours of life
measure: Rate of Late Onset Sepsis
timeFrame: From > 72 hours of life through study completion at death or discharge, up to 6 months of corrected gestational age
Locations:
city: Davis
country: United States
facility: University of California Davis
state: California
city: San Diego
country: United States
facility: University of California San Diego Jacobs Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
Study officials:
affiliation: Sharp HealthCare
name: Anup Katheria, MD
role: PRINCIPAL_INVESTIGATOR
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