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

Infant Weight Gain With Trisomy 21 and CAVC

14. marts 2012 opdateret af: Children's Healthcare of Atlanta

The Impact of Weight Gain in the Pre-operative Infant With Trisomy 21 (Down Syndrome) and Complete Atrioventricular Canal (CAVC)

Failure to thrive and difficulty gaining weight is a sign of uncompensated congestive heart failure (CHF). Infants with Trisomy 21 and complete atrioventricular canal defects (CAVC) frequently develop uncompensated CHF and weight gain failure pre-operatively. A weight of 5 kg has been suggested as optimal for timing of CAVC repair. A delay in surgical repair often occurs if weight gain stalls and reaches a plateau prior to reaching 5 kg. A retrospective review performed by Kogon, et al, of children undergoing surgery for VSD at CHOA at Egleston recently reported that age and weight at surgery may not, however, be associated with adverse surgical outcome.

The purpose of this study is to determine the optimal timing for surgical correction of CAVC in Trisomy 21 infants based on reaching a plateau of failed weight gain despite maximal anti-congestive and nutritional therapy.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

A retrospective chart review of 100 infants with Trisomy 21 and CAVC operated at CHOA at Egleston between January 1, 2001 and March 24, 2006 will be performed. Graphs of birth weight and rate of weight gain over time will be plotted for each patient and for the group as a whole. The point of reaching a plateau of weight gain will be decided for each patient and indexed for birth weight. Medical management will be detailed, i.e. all medications and all dietary information (caloric density of formula, route of administration). This medical management will be indexed as a function on the weight gain chart. Medical complications (such as respiratory infections, gastroenteritis, hospitalizations, and additional non-cardiac medications) will likewise be plotted and segmented according to position relative to the weight gain plateau. Age at eventual surgery and whether surgical date was delayed by complications will be noted. Surgical cardiopulmonary bypass time and morbidity and mortality will be noted. Postoperative length of ventilator support, length of stay in the CICU and total length of stay will be determined and also displayed as a function of body weight and as a function of time at plateau weight. Postoperative morbidity and mortality for the three months after repair will be noted, including all cause hospital re-admissions and outpatient medical complications (such as respiratory infections, gastroenteritis, and the need for continued medications for CHF).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

46

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Children's Healthcare of Atlanta

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

Ikke ældre end 1 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

patients' charts from Children's Healthcare of Atlanta

Beskrivelse

Inclusion Criteria:

  • Infants with Trisomy 21 and CAVC operated on at CHOA at Egleston between January 1, 2001 and December 31, 2005 will be included in the study.

Exclusion Criteria:

  • Patients will be excluded if the following information is not available:

A. Birth weight B. Weight at operation C. Incomplete medical records e.g. patient followed preoperatively elsewhere

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Samarbejdspartnere og efterforskere

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

Sponsor

Children's Healthcare of Atlanta

Efterforskere

  • Ledende efterforsker: Tracy M Alderson, MD, Emory University @ Children's Healthcare of Atlanta

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. januar 2001

Primær færdiggørelse (Faktiske)

1. marts 2006

Studieafslutning (Faktiske)

1. februar 2008

Datoer for studieregistrering

Først indsendt

18. maj 2006

Først indsendt, der opfyldte QC-kriterier

18. maj 2006

Først opslået (Skøn)

19. maj 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. marts 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. marts 2012

Sidst verificeret

1. februar 2008

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 06-109

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 Medfødte lidelser

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Angola

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner