Fluid Restriction in Respiratory Distress of the Newborn



Status:Recruiting
Conditions:Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:Any
Updated:5/4/2018
Start Date:March 1, 2017
End Date:December 2020
Contact:Abhishek Makkar, MD
Email:abhishek-makkar@ouhsc.edu
Phone:405-271-5215

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Multicenter Randomized Controlled Trial Of Restrictive Fluid Management For Respiratory Distress in the Newborn Period

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.
We found this trial at
2
sites
Lawton, Oklahoma 73505
Phone: 717-215-5056
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Phone: 212-241-6186
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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