Clinical trial NCT02742454: VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants
Official title: VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intraventricular Hemorrhage
Keywords: Umbilical Cord Clamping
Intraventricular Hemorrhage
Extremely Preterm Infants
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Mayo Clinic
name: St. Louis University
name: University of Colorado, Denver
name: Oregon Health and Science University
name: University of Calgary
name: Columbia University
name: Indiana University
name: University of California, Davis
name: University of Alberta
name: University of Alabama at Birmingham
First posted: 2016-04-19
Enrollment: 570
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether providing ventilatory assistance prior to umbilical cord clamping influences the occurrence of intraventricular hemorrhage (IVH) in extremely preterm (EPT) infants, compared to standard care of providing ventilatory assistance after cord clamping.

Detailed description: Newborns with gestational age 23 wks 0 days through 28 wks 6 days are randomized to control (delayed cord clamping for at least 30 seconds, or up to 60 seconds if breathing spontaneously, with ventilatory assistance provided after) or the VentFirst intervention (ventilatory assistance with continuous positive airway pressure or positive pressure ventilation given starting 30 seconds after birth and cord clamping at 120 seconds).

The primary outcome is lack of IVH on 7-10 day head ultrasound or death before day 7.

The study was designed to test the impact of the intervention in each of two cohorts:

1. Infants not breathing well 30 seconds after birth
2. Infants breathing well 30 seconds after birth

Randomization and analysis is stratified by gestational age category:

1. 23 0/6 to 25 6/7 weeks' gestation
2. 26 0/7 to 28 6/7 weeks' gestation

Eligibility criteria: Inclusion Criteria:

* 23 0/7 - 28 6/7 weeks' gestation at delivery

Exclusion Criteria:

* Life-threatening condition of fetus (e.g. severe hydrops, lethal chromosomal abnormality, severe congenital malformation)
* Suspected severe fetal anemia
* Monochorionic or monoamniotic twins
* Multiple gestation greater than twins
* Decision made for comfort care only
* Medical emergency necessitating emergency delivery (e.g. complete placental abruption)
* Obstetrician or Neonatology concern for inappropriateness of the study intervention based on maternal or fetal factors.

Primary outcomes:
measure: Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age
timeFrame: 7-10 days after birth
Secondary outcomes:
measure: 5 minute Apgar Score <5
timeFrame: 5 minutes after birth
measure: Lowest hematocrit in first 24 hours
timeFrame: First 24 hours after birth
measure: Medication for low blood pressure in first 24 hours
timeFrame: First 24 hours after birth
measure: Number of red blood cell transfusions birth through day 10
timeFrame: First 10 days after birth
measure: Severe brain injury on head ultrasound
timeFrame: Birth through 36 weeks' postmenstrual age
measure: Death
timeFrame: Birth through 36 weeks' postmenstrual age
Other outcomes:
measure: Maternal post-partum hemorrhage
timeFrame: First 24 hours after delivery
measure: Maternal red blood cell transfusion
timeFrame: Prior to maternal hospital discharge
measure: Maternal retained placenta
timeFrame: Prior to hospital discharge
measure: Maternal post-partum delivery related infection
timeFrame: Prior to maternal hospital discharge
measure: Apgar scores
timeFrame: 1 minute, 5 minutes, and 10 minutes after delivery
measure: Umbilical Cord Blood Gas
timeFrame: In delivery room
measure: Chest compressions or epinephrine
timeFrame: In delivery room
measure: Volume Bolus
timeFrame: In delivery room
measure: Intubation
timeFrame: In delivery room
measure: Admission hypothermia <36.5°C
timeFrame: at admission to the Neonatal Intensive Care Unit
measure: Pneumothorax
timeFrame: first 24 hours after delivery
measure: NICU admission temperature
timeFrame: At NICU admission
measure: SNAPPE-II Score
timeFrame: First 12 hours after birth
measure: Red blood cell transfusion
timeFrame: First 24 hours after birth
measure: Highest hematocrit
timeFrame: First 24 hours after birth
measure: Lowest mean arterial blood pressure
timeFrame: First 24 hours after birth
measure: Volume Bolus
timeFrame: First 24 hours after birth
measure: Surfactant administration
timeFrame: First 10 days after birth
measure: Mechanical ventilation days
timeFrame: First 10 days after birth
measure: Early-Onset Septicemia
timeFrame: <72 hours after birth
measure: Highest bilirubin
timeFrame: First 10 days after birth
measure: Phototherapy duration
timeFrame: First 10 days after birth
measure: Intraventricular hemorrhage
timeFrame: Prior to 36 weeks' postmenstrual age
measure: Cerebellar hemorrhage
timeFrame: Prior to 36 weeks' postmenstrual age
measure: Late-Onset Septicemia
timeFrame: Prior to 36 weeks' postmenstrual age
measure: Cystic Periventricular Leukomalacia (cPVL)
timeFrame: Prior to 36 weeks' postmenstrual age
measure: Patent Ductus Arteriosus (PDA)
timeFrame: Prior to 36 weeks' postmenstrual age
measure: Spontaneous intestinal perforation (SIP)
timeFrame: Prior to 36 weeks' postmenstrual age
measure: Necrotizing Enterocolitis (NEC)
timeFrame: Prior to 36 weeks' postmenstrual age
measure: Bronchopulmonary Dysplasia (BPD)
timeFrame: At 36 weeks' postmenstrual age
measure: Severe ROP
timeFrame: Prior to 36 weeks' postmenstrual age
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Indianapolis
country: United States
facility: University of Indiana
state: Indiana
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta, Edmonton
state: Alberta
Study officials:
affiliation: University of Virginia
name: Karen Fairchild, MD
role: PRINCIPAL_INVESTIGATOR
References: