Respiratory Distress Syndrome, Newborn
Conditions
Keywords
Respiratory Distress Syndrome, Newborn, fluid restriction
Brief summary
The object of this study is to determine the best way to care for infants with respiratory distress. The investigators are testing a method of feeding fluids to infants with respiratory distress in amounts similar to what healthy breastfed babies eat when they are feeding on demand, and comparing this method to the current standard of care for feeding fluids to infants with respiratory distress. These methods of feeding fluids to the study infants will continue until the infants are able to feed normally by mouth. The study will include about 400 infants across five sites in the United States, Chile and Argentina.
Detailed description
Infants with respiratory distress syndrome will be enrolled within the first twelve hours of life, and randomly assigned to one of two groups: the first group will receive the interventional fluid management method, and the second (the control group) will receive the current standard of care for fluid management. To standardize respiratory care across all five study sites, a computer-based algorithm for respiratory support management based on objective markers of respiratory distress will guide clinician management decisions. However, each infant's medical team will make all final decisions on respiratory treatment and IV fluid management. Any study infant who experiences dehydration and/or low blood sugar during the course of the study will be removed from the study and be treated for the condition.
Interventions
OTHERFluid Management Intervention
Fluid management intervention is fluid restriction to 60 mL/kg/day on Day of Life (DOL) 1 for preterm and 40 mL/kg/day on DOL 1 for term neonates, calculated as total of IV and enteral fluid intake. Infants randomized to low infusion with be placed on 10% dextrose and the Infant will be monitored by obtaining serum glucose levels by point of care testing. Glucose infusion rates (GIR) would be calculated to the corresponding serum glucose and recorded. After 24 hours, infusion rate will be increased to 60ml/kg/d providing minimum GIR \>4mg/kg/d. . Total fluid intake will be increased by 20 mL/kg/day until 150 mL/kg/day .
Sponsors
Icahn School of Medicine at Mount Sinai
Universidad Abierta Interamericana
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Hours
Healthy volunteers
No
Inclusion criteria
* Neonates born between 34-0/7 and 41-6/7 weeks gestational age (GA) at birth with primary pulmonary disease of the newborn including Transient Tachypnea of the Newborn (TTN), Respiratory Distress Syndrome (RDS), air leak syndrome, pneumonia, or meconium aspiration syndrome in the first 12 hours of life will be eligible for inclusion in this study. * Those neonates who are intubated for administration of exogenous surfactant but who are immediately extubated to non-invasive respiratory support after surfactant administration will remain eligible for study inclusion.
Exclusion criteria
* Neonates with a genetic abnormality or congenital anatomic anomaly Subsequent Study Exclusion resulting in removal from study: * Neonates who subsequently undergo endotracheal intubation and mechanical ventilation for refractory respiratory distress * Neonates with hypoglycemia or clinical evidence of dehydration or volume depletion requiring fluid bolus * Infants that are transported out of the participating site prior to study endpoint.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from birth to first oral feeding | every 24 hours for up to 168 hours | Total Hours until first oral feeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Respiratory Support | every 3 hours for up to 168 hours | Total hours of Respiratory Support |
| Total Duration of NICU stay | every 24 hours up to 12 weeks | Length of Stay in the NICU |
Countries
United States
Outcome results
None listed