Clinical trial NCT03120585: Fluid Restriction in Respiratory Distress of the Newborn
Official title: Multicenter Randomized Controlled Trial Of Restrictive Fluid Management For Respiratory Distress in the Newborn Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Keywords: Respiratory Distress Syndrome, Newborn
fluid restriction
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: Universidad Abierta Interamericana
First posted: 2017-04-19
Enrollment: 65
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time from birth to first oral feeding
timeFrame: every 24 hours for up to 168 hours
Secondary outcomes:
measure: Duration of Respiratory Support
timeFrame: every 3 hours for up to 168 hours
measure: Total Duration of NICU stay
timeFrame: every 24 hours up to 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Lawton
country: United States
facility: Comanche county Memorial hospital
state: Oklahoma
Study officials:
affiliation: University of Oklahoma HSC
name: Abhishek Makkar, MD
role: STUDY_DIRECTOR
References:
citation: Bell EF, Acarregui MJ. Restricted versus liberal water intake for preventing morbidity and mortality in preterm infants. Cochrane Database Syst Rev. 2014;2014(12):CD000503. doi: 10.1002/14651858.CD000503.pub3. Epub 2014 Dec 4.
citation: Stroustrup A, Trasande L, Holzman IR. Randomized controlled trial of restrictive fluid management in transient tachypnea of the newborn. J Pediatr. 2012 Jan;160(1):38-43.e1. doi: 10.1016/j.jpeds.2011.06.027. Epub 2011 Aug 11.