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    Journal

    Randomized Controlled Trial ofRestrictive Fluid Management in

    Transient Tachypnea of the Newborn

    Perceptors:

    dr. Manan Affandi, Sp. A

    dr. Rachmat Gumelar, Sp. Adr. Tina Ramayanthi, Sp. A

    CUT RADHIAH SWADIA

    1102008062

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    Transient tachypnea of the newborn(TTN)

    Transient tachypnea of the newborn (TTN) is a self-limitedrespiratory distress syndrome of term and late preterm neonates

    related to poor clearance of fetal lung fluid after delivery.

    Neonates with TTN have inefficient transitionfrom in utero to exutero pulmonary function due to delayed ion channel switching inthe pulmonary epithelium

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    We hypothesized that mild fluid restriction in the first days oflife, mimicking physiological low fluid intake by exclusivelybreast-fed neonates, would speed resolution of TTN-relatedrespiratory distress.

    We randomized patients to receive either standard of caredaily total fluids or a more restrictive fluid management

    strategy.

    The primary study outcome was duration of respiratorysupport . Additional secondary analysis focused on the costsof hospitalization of enrolled patients.

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    Methods

    This was a single-centerstudy of inborn neonatesat our urban tertiary carecenter that delivers morethan 6000 babiesannually.

    Neonates born between 34-0/7and 41-6/7 weeks gestationalage (GA) diagnosed withuncomplicated TTN in the first 12hoursof life were eligible forinclusion in this study.Patients were recruited at

    our institution from August1, 2008, through September2, 2010.The study was registeredwith ClinicalTrials.gov

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    Neonates were alternately assigned to receive standard-ofcare fluids or fluid restriction based on the diagnosis of TTN.

    Standard-of-care totalfluids was defined : 80 mL/kg/day on day

    of life (DOL) 1 forpreterm neonates(those born between34-0/7 and 36-6/7weeks GA)

    60 mL/kg/day on DOL1 for term neonates(those born between37-0/7 and 41-6/7weeks GA).

    Fluid restriction wasdefined as :

    60 mL/kg/dayon DOL 1 for pretermneonates and

    40 mL/kg/day on DOL1 for term neonates.

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    Result

    A total of 73 neonates met the enrollmentcriteria, and the parents of 67 eligibleneonates agreed to participate.

    Of these 67 neonates, 34 were assigned tostandard-of-care fluid management and 33were assigned to the restricted fluidprotocol.

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    At the time of diagnosis of uncomplicated TTN, patients can

    be categorized into mild or moderatesevere TTN.

    The distinction between moderate and severe TTN cannot be

    made until 48 hours of life. However, because our fluidrestriction protocol appears to be safe in all patients with

    TTN, we suggest initiating fluid restriction for all patients with

    moderate or severe uncomplicated TTN, to benefit those who

    ultimately demonstrate severe disease.

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    Given that fluid restriction in late preterm and term

    neonates with respiratory distress is a novel

    therapy, there was significant concern among both

    treating physicians in our NICU and committeemembers of our Institutional ReviewBoard that

    patients in our intervention cohort would face

    significant dehydration, weight loss, and/or

    hypoglycemia.

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    We found a significant ($5808) total cost savings perpatient with severeTTN that received restricted fluidmanagement.

    If the savings and patient demographics seen in ourstudy were replicated nationally, then, using even aconservative estimate of the true incidence of TTN, mildfluid restriction could result in an annual savings of morethan $100 million in the United States alone.

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    Here we report the first randomized controlled trial of fluidmanagement in TTN. We demonstrate the safety of mild fluidrestriction in late preterm and term neonates with TTN, andpropose an evidence-based management strategy to speed

    symptom resolution in neonates with severe TTN.

    Our management strategy provides significant clinical andfinancial benefits to neonates with uncomplicated severe TTN.

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