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Fluid Restriction in Respiratory Distress of the Newborn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03120585
Recruitment Status : Recruiting
First Posted : April 19, 2017
Last Update Posted : May 2, 2018
Icahn School of Medicine at Mount Sinai
Universidad Abierta Interamericana
Information provided by (Responsible Party):
Abhishek Makkar, MD, University of Oklahoma

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Newborn Other: Fluid Management Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Controlled Trial Of Restrictive Fluid Management For Respiratory Distress in the Newborn Period
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Fluid Management Intervention
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)
Other: Fluid 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 .

No Intervention: Control Group
Infants with respiratory distress will receive standard of care fluid management.

Primary Outcome Measures :
  1. Time from birth to first oral feeding [ Time Frame: every 24 hours for up to 168 hours ]
    Total Hours until first oral feeding

Secondary Outcome Measures :
  1. Duration of Respiratory Support [ Time Frame: every 3 hours for up to 168 hours ]
    Total hours of Respiratory Support

  2. Total Duration of NICU stay [ Time Frame: every 24 hours up to 12 weeks ]
    Length of Stay in the NICU

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03120585

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Contact: Abhishek Makkar, MD 405-271-5215
Contact: Annemarie Stroustrup, MD 212-241-6186

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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029-5674
Contact: Annemarie Stroustrup, MD    212-241-6186      
United States, Oklahoma
Comanche county Memorial hospital Recruiting
Lawton, Oklahoma, United States, 73501
Contact: Abhishek Makkar, M.D    717-215-5056   
Sponsors and Collaborators
Abhishek Makkar, MD
Icahn School of Medicine at Mount Sinai
Universidad Abierta Interamericana
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Study Director: Abhishek Makkar, MD University of Oklahoma HSC

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Responsible Party: Abhishek Makkar, MD, Assistant Professor of Pediatrics, Neonatal-Perinatal Medicine, University of Oklahoma Identifier: NCT03120585     History of Changes
Other Study ID Numbers: 4688
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abhishek Makkar, MD, University of Oklahoma:
Respiratory Distress Syndrome, Newborn
fluid restriction
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases