Intraventricular Hemorrhage
Conditions
Keywords
Umbilical Cord Clamping, Intraventricular Hemorrhage, Extremely Preterm Infants
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
Interventions
PROCEDUREStandard 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.
PROCEDUREVentFirst 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.
Sponsors
Brigham and Women's Hospital
Mayo Clinic
St. Louis University
University of Colorado, Denver
Oregon Health and Science University
University of Calgary
Columbia University
Indiana University
University of California, Davis
University of Alberta
University of Alabama at Birmingham
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Board-certified radiologists interpreting head ultrasound findings are blinded to study arm. Consensus on maximum grade of IVH between two radiologists (some combination of site radiologist and one of three external readers blinded to each others' interpretation) is required.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age | 7-10 days after birth | presence of any grade IVH on HUS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lowest hematocrit in first 24 hours | First 24 hours after birth | Median, 25th & 75th percentiles |
| Medication for low blood pressure in first 24 hours | First 24 hours after birth | Hydrocortisone and/or vasopressor for hypotension |
| 5 minute Apgar Score <5 | 5 minutes after birth | Low Apgar score (\<5) at 5 minutes |
| Severe brain injury on head ultrasound | Birth through 36 weeks' postmenstrual age | 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 |
| Death | Birth through 36 weeks' postmenstrual age | All-cause mortality |
| Number of red blood cell transfusions birth through day 10 | First 10 days after birth | Median, 25th & 75th percentiles |
Other
| Measure | Time frame | Description |
|---|---|---|
| Volume Bolus | In delivery room | administration of a volume bolus |
| Intubation | In delivery room | Endotracheal intubation |
| Admission hypothermia <36.5°C | at admission to the Neonatal Intensive Care Unit | \<36.5°C |
| Pneumothorax | first 24 hours after delivery | Diagnosis of pneumothorax requiring intervention |
| NICU admission temperature | At NICU admission | Infant's NICU admission temperature |
| SNAPPE-II Score | First 12 hours after birth | Score for Neonatal Acute Physiology-Perinatal Extension |
| Red blood cell transfusion | First 24 hours after birth | Administration of an RBC transfusion |
| Highest hematocrit | First 24 hours after birth | Infant's highest hematocrit (before transfusion) |
| Lowest mean arterial blood pressure | First 24 hours after birth | Infant's lowest mean arterial blood pressure (cuff or arterial catheter) |
| Surfactant administration | First 10 days after birth | Administration of surfactant |
| Mechanical ventilation days | First 10 days after birth | Number of days on mechanical ventilation via an endotracheal tube |
| Maternal post-partum hemorrhage | First 24 hours after delivery | \>= 1000 mL estimated blood loss |
| Highest bilirubin | First 10 days after birth | Highest bilirubin recorded |
| Phototherapy duration | First 10 days after birth | Number of days on phototherapy |
| Intraventricular hemorrhage | Prior to 36 weeks' postmenstrual age | Highest grade of IVH |
| Cerebellar hemorrhage | Prior to 36 weeks' postmenstrual age | occurrence of cerebellar hemorrhage |
| Late-Onset Septicemia | Prior to 36 weeks' postmenstrual age | Positive blood culture after first 3 days and treated with at least 5 days of antibiotics |
| Cystic Periventricular Leukomalacia (cPVL) | Prior to 36 weeks' postmenstrual age | Occurrence of cPVL |
| Patent Ductus Arteriosus (PDA) | Prior to 36 weeks' postmenstrual age | occurrence of PDA requiring pharmacological or surgical treatment |
| Spontaneous intestinal perforation (SIP) | Prior to 36 weeks' postmenstrual age | SIP without NEC and requiring surgery or peritoneal drain |
| Necrotizing Enterocolitis (NEC) | Prior to 36 weeks' postmenstrual age | Occurrence of NEC modified Bell's stage 2-3 |
| Bronchopulmonary Dysplasia (BPD) | At 36 weeks' postmenstrual age | Occurrence of BPD receiving continuous supplemental oxygen |
| Severe ROP | Prior to 36 weeks' postmenstrual age | occurrence of ROP stage 3 or treated with laser or bevacizumab |
| Early-Onset Septicemia | <72 hours after birth | Positive blood culture in first 3 days and treated with at least 5 days of antibiotics |
| Maternal red blood cell transfusion | Prior to maternal hospital discharge | Administration of an RBC transfusion |
| Maternal retained placenta | Prior to hospital discharge | Retained placenta |
| Maternal post-partum delivery related infection | Prior to maternal hospital discharge | Diagnosis of a delivery related infection |
| Apgar scores | 1 minute, 5 minutes, and 10 minutes after delivery | Apgar scores taken in the delivery room (1, 5, 10 minutes) |
| Umbilical Cord Blood Gas | In delivery room | Umbilical cord venous and arterial pH |
| Chest compressions or epinephrine | In delivery room | occurrence of infant chest compressions or administration of epinephrine |
Countries
Canada, United States
Outcome results
None listed