Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial (GMT)

24. juli 2020 opdateret af: Sudarshan Jadcherla

Pathophysiology of the Aerodigestive Reflex in Infants: GERD Management Trial

The overall purpose of the investigator's study is to evaluate the causes of and treatment for feeding difficulty in infants with Gastro-esophageal Reflux Disease (GERD). New treatments can be possible only if the cause is known. Many infants have GERD and feeding difficulties, such as sucking and swallowing problems, vomiting, or delayed emptying of the stomach. Some of these infants have difficulty in protecting their airway during feeding or during reflux, and as a result can breathe fluid into their lungs or hold their breath. Most GERD treatments are done based on experience, but there is no scientific proof that these methods work for infants. GERD and feeding difficulties can lead to longer hospitalization and more stress for the family.

In this clinical trial, the investigators are developing new methods to help with diagnosis as well as defining better treatment strategies in relieving GERD and GERD complications.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Gastroesophageal reflux disease (GERD) and its troublesome complications constitute serious diagnostic and management challenges to the development of safe feeding and airway protection strategies among infants convalescing in the neonatal intensive care units; thus contributing to prolonged lengths of stay, recurrent hospitalizations, and death. GERD is frequently diagnosed by inadequate criteria, and the relative risks, benefits and indications of GERD therapies are unclear. Significant gaps in knowledge exist in understanding the complex causal or adaptive aerodigestive protective reflex mechanisms implicated in GERD in infants. The long-term goal is to improve digestive health, nutrition, and infant development through the design of simplified personalized treatment paradigms by better understanding the pathophysiology of aerodigestive reflexes.

The current objective is to conduct a prospective single center randomized blinded controlled trial comparing the short term effects of the investigators innovative feeding strategy bundle (study approach) versus standard feeding approach (conventional approach).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

76

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43205
        • The Research Institute at Nationwide Children's Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

7 måneder til 1 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Hospitalized infants with aerodigestive or GERD symptoms
  • Gestational age ≤42 weeks
  • Premature infants are eligible at 34 weeks postmenstrual age (PMA)
  • Enteral or Oral Fed
  • Average daily total feeding volume ≥ 150ml/kg/day
  • Room air or supplemental oxygen of ≤1 liter/minute (LPM) and/or ≤ 35% by nasal cannula

Exclusion Criteria:

  • Known genetic, metabolic or syndromic disease
  • Neurological diseases such as Grade 3 or 4 intraventricular hemorrhage (IVH) or intracranial hemorrhage (ICH) and perinatal asphyxia
  • Gastrointestinal malformations and surgical gastrointestinal conditions

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Study
Treated with omeprazole. This group of subjects will have prescribed restricted feeding volumes, monitored feeding duration time and positioning restrictions
Andet: Study Arm - acid suppression plus feeding bundle
  • Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID)
  • Total fluid volume restriction (120-140 milliliters/kilogram/day)
  • Feeding duration over 30 minutes
  • Infant feeds with right side down
  • Infant is placed on back following feeds
Andet: Conventional
Treated with omeprazole. This group of subjects will receive the current standard treatment for Gastro-esophageal reflux disease (GERD) which includes use of acid suppressive medication with no restrictions of the feeding volume, duration or positioning.
Andet: Conventional arm - acid suppression only
-Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CLINICAL OUTCOME OF FEEDING SUCCESS
Tidsramme: Up to 5 weeks after enrollment
The primary endpoint is the feeding success defined as achieving full oral feeds (defined as no need for tube feeds to maintain hydration and nutrition) and/or a >/= 6 point decrease from baseline symptom score as described by the Infant-Gastro-Esophageal Reflux Questionnaire-Revised. The minimum score is 0 (no symptoms) and the maximum score is 42 (maximum symptoms). Any total score greater than or equal to 16 is considered abnormal.
Up to 5 weeks after enrollment
MOTILITY OUTCOMES: Presence of Esophageal Peristaltic Reflexes
Tidsramme: 5 weeks
This is part of Aim 2 of this RCT, which is a mechanistic outcome designed to understand the reasons for the clinical outcome. Presence of peristaltic reflex mechanisms elicited upon esophageal provocation during esophageal manometry were compared within the groups, week-5 vs. week-0. Odds ratios (ORs) with 95% confidence interval (CI) are reported from Generalized Estimation Equation models.
5 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CLINICAL OUTCOMES: Growth Outcome Measure
Tidsramme: at 5 weeks
Growth: The investigators will measure and track weight growth velocity during the study period
at 5 weeks
CLINICAL OUTCOME: Development Outcome Measures
Tidsramme: Up to 1 year age
Feeding Milestones: The investigators will track feeding method at 1 year.
Up to 1 year age
CLINICAL OUTCOME: Respiratory Outcome Measures
Tidsramme: at discharge
Supplemental oxygen requirement at discharge was recorded for both groups
at discharge

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sudarshan Jadcherla

Samarbejdspartnere

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Ohio State University

Efterforskere

  • Ledende efterforsker: Sudarshan R Jadcherla, MD, The Research Institute at Nationwide Children's Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2012

Primær færdiggørelse (Faktiske)

31. marts 2020

Studieafslutning (Faktiske)

31. marts 2020

Datoer for studieregistrering

Først indsendt

17. juni 2015

Først indsendt, der opfyldte QC-kriterier

26. juni 2015

Først opslået (Skøn)

1. juli 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juli 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juli 2020

Sidst verificeret

1. juli 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 11-00734
  • R01DK068158 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Gastroøsofageal reflukssygdom

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Congo, DR of

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner