Fluid Restriction in Respiratory Distress of the Newborn
Fluid Restriction in Respiratory Distress of the Newborn
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.
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.
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.