Fluid Restriction in Respiratory Distress of the Newborn

University of Oklahoma (OU)

Status: Completed

Conditions: Respiratory Distress Syndrome, Newborn

Treatments: Other: Fluid Management Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03120585

4688

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: Under 12 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Fluid Management Intervention

Experimental group

Description:

Restricting IV fluids to infants with respiratory distress to mimic fluid intake of normal healthy breast fed infants (less fluid that current standard of care)

Treatment:

Other: Fluid Management Intervention

Control Group

No Intervention group

Description:

Infants with respiratory distress will receive standard of care fluid management.