VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants

Intraventricular Hemorrhage Clinical Trial

Official title:

VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02742454
• Other study ID #: 18783
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 570
• Est. completion date: December 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Intraventricular Hemorrhage

Intervention

Procedure:
• Standard 30-60 Seconds Cord Clamping
The infant is stimulated to breathe after birth. If the infant is not breathing well, the cord is clamped at 30 seconds. If the baby is breathing well, the cord is clamped at 60 seconds. Ventilatory assistance is given after cord clamping.
• VentFirst 120 Seconds Cord Clamping
The infant is stimulated to breathe after birth. If the infant is not breathing well, PPV by face mask is given starting at 30 seconds. If the baby is breathing well, CPAP is given starting at 30 seconds. The cord is clamped at 120 seconds.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta, Edmonton	Edmonton	Alberta
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	University of Colorado	Denver	Colorado
United States	University of Indiana	Indianapolis	Indiana
United States	Columbia University Medical Center	New York	New York
United States	Oregon Health & Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California, Davis	Sacramento	California
United States	St. Louis University	Saint Louis	Missouri

Sponsors (12)

Lead Sponsor	Collaborator
University of Virginia	Brigham and Women's Hospital, Columbia University, Indiana University, Mayo Clinic, Oregon Health and Science University, St. Louis University, University of Alabama at Birmingham, University of Alberta, University of Calgary, University of California, Davis, University of Colorado, Denver

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal post-partum hemorrhage	>= 1000 mL estimated blood loss	First 24 hours after delivery
Other	Maternal red blood cell transfusion	Administration of an RBC transfusion	Prior to maternal hospital discharge
Other	Maternal retained placenta	Retained placenta	Prior to hospital discharge
Other	Maternal post-partum delivery related infection	Diagnosis of a delivery related infection	Prior to maternal hospital discharge
Other	Apgar scores	Apgar scores taken in the delivery room (1, 5, 10 minutes)	1 minute, 5 minutes, and 10 minutes after delivery
Other	Umbilical Cord Blood Gas	Umbilical cord venous and arterial pH	In delivery room
Other	Chest compressions or epinephrine	occurrence of infant chest compressions or administration of epinephrine	In delivery room
Other	Volume Bolus	administration of a volume bolus	In delivery room
Other	Intubation	Endotracheal intubation	In delivery room
Other	Admission hypothermia <36.5°C	<36.5°C	at admission to the Neonatal Intensive Care Unit
Other	Pneumothorax	Diagnosis of pneumothorax requiring intervention	first 24 hours after delivery
Other	NICU admission temperature	Infant's NICU admission temperature	At NICU admission
Other	SNAPPE-II Score	Score for Neonatal Acute Physiology-Perinatal Extension	First 12 hours after birth
Other	Red blood cell transfusion	Administration of an RBC transfusion	First 24 hours after birth
Other	Highest hematocrit	Infant's highest hematocrit (before transfusion)	First 24 hours after birth
Other	Lowest mean arterial blood pressure	Infant's lowest mean arterial blood pressure (cuff or arterial catheter)	First 24 hours after birth
Other	Volume Bolus	Any volume bolus including the delivery room, and including NICU packed red blood cells, platelets, plasma, saline, or other fluid bolus	First 24 hours after birth
Other	Surfactant administration	Administration of surfactant	First 10 days after birth
Other	Mechanical ventilation days	Number of days on mechanical ventilation via an endotracheal tube	First 10 days after birth
Other	Early-Onset Septicemia	Positive blood culture in first 3 days and treated with at least 5 days of antibiotics	<72 hours after birth
Other	Highest bilirubin	Highest bilirubin recorded	First 10 days after birth
Other	Phototherapy duration	Number of days on phototherapy	First 10 days after birth
Other	Intraventricular hemorrhage	Highest grade of IVH	Prior to 36 weeks' postmenstrual age
Other	Cerebellar hemorrhage	occurrence of cerebellar hemorrhage	Prior to 36 weeks' postmenstrual age
Other	Late-Onset Septicemia	Positive blood culture after first 3 days and treated with at least 5 days of antibiotics	Prior to 36 weeks' postmenstrual age
Other	Cystic Periventricular Leukomalacia (cPVL)	Occurrence of cPVL	Prior to 36 weeks' postmenstrual age
Other	Patent Ductus Arteriosus (PDA)	occurrence of PDA requiring pharmacological or surgical treatment	Prior to 36 weeks' postmenstrual age
Other	Spontaneous intestinal perforation (SIP)	SIP without NEC and requiring surgery or peritoneal drain	Prior to 36 weeks' postmenstrual age
Other	Necrotizing Enterocolitis (NEC)	Occurrence of NEC modified Bell's stage 2-3	Prior to 36 weeks' postmenstrual age
Other	Bronchopulmonary Dysplasia (BPD)	Occurrence of BPD receiving continuous supplemental oxygen	At 36 weeks' postmenstrual age
Other	Severe ROP	occurrence of ROP stage 3 or treated with laser or bevacizumab	Prior to 36 weeks' postmenstrual age
Primary	Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age	presence of any grade IVH on HUS	7-10 days after birth
Secondary	5 minute Apgar Score <5	Low Apgar score (<5) at 5 minutes	5 minutes after birth
Secondary	Lowest hematocrit in first 24 hours	Median, 25th & 75th percentiles	First 24 hours after birth
Secondary	Medication for low blood pressure in first 24 hours	Hydrocortisone and/or vasopressor for hypotension	First 24 hours after birth
Secondary	Number of red blood cell transfusions birth through day 10	Median, 25th & 75th percentiles	First 10 days after birth
Secondary	Severe brain injury on head ultrasound	Grade 3-4 IVH and/or cerebellar hemorrhage and/or cystic periventricular leukomalacia on head ultrasound at 7-10 days of age and/or near 36 weeks' postmenstrual age	Birth through 36 weeks' postmenstrual age
Secondary	Death	All-cause mortality	Birth through 36 weeks' postmenstrual age