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Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns

11. august 2014 opdateret af: Han-Suk Kim, Seoul National University Hospital
Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants. However, most of them could not proceed enteral feedings due to clinical instability in the first few days. Recent studies supports oropharyngeal administration as a potentially safe and effective delivery method for immunologic benefits and only small amount of colostrum could be administrated for immune therapy for extremely premature babies. The purpose of this study is to determine the beneficial effects of oropharyngeal administration of colostrum for immunologic aspects in extremely low gestational age infants and evaluated the safety of this method to extremely premature infants in the first few days of life.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Korea, Republikken
      • Seoul, Korea, Republikken, 110-744
        • Seoul National University 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

2 dage til 4 dage (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • premature infant with a gestational age less than 28 weeks born at Seoul National University Hospital and admit to the Seoul National University Children's Hospital NICU immediately after birth
  • parents of the infant signed to the informed consent form with voluntary agreement

Exclusion Criteria:

  • infants with major congenital anomalies or chromosomal syndromes
  • infants of mothers not willing to provide colostrum in the first week of life
  • infants of mothers with known infectious diseases that may be transmitted through the breast milk such as HIV, hepatitis C or active TB

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Colostrum
oropharyngeal administration of own mother's colostrum
Andet: oropharyngeal administration of own mother's colostrum
application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
Placebo komparator: Placebo
oropharyngeal administration of sterile water
Andet: oropharyngeal administration of sterile water
application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Urinary Secretary IgA Concentration at 2 Weeks of Age
Tidsramme: 2 weeks of age
2 weeks of age

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Urinary Secretary IgA Concentration at 1 Week of Age
Tidsramme: 1 week of age
1 week of age
Salivary TGF-beta 1 Concentration at 2 Week of Age
Tidsramme: 2 week of age
2 week of age
Salivary IL-8 Concentration at 2 Weeks of Age
Tidsramme: 2 weeks of age
2 weeks of age
Concentration of Urinary Lactoferrin
Tidsramme: 1 week of age
1 week of age
Concentration of Urinary IL-1 Beta
Tidsramme: 2 weeks of age
2 weeks of age
Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines
Tidsramme: 1 week of age
1 week of age
Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines
Tidsramme: 2 weeks of age
2 weeks of age
Time to Reach Full Feeding
Tidsramme: up to 2 months of age
day of life when the baby reaches full enteral feeding, defined as a volume above 120~130mL/kg/day
up to 2 months of age
Total Hospital Admission Duration
Tidsramme: up to 4 months of age
days from admission to discharge from NICU
up to 4 months of age
Episodes of Culture Positive Sepsis
Tidsramme: from date of randomization up to 4 months of age
numbers of documented sepsis events defined as isolation of the microorganism from ≥ 1 blood culture + ≥ 1 clinical symptoms or sign (fever, hypothermia, apnea, bradycardia, hypo-/hyperglycemia)
from date of randomization up to 4 months of age
Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2
Tidsramme: from date of randomization up to 4 months of age
from date of randomization up to 4 months of age
Episodes of Pneumonia
Tidsramme: from date of randomization up to 4 months of age
numbers of documented pneumonia events those accompanied with increased tracheal secretion, increased ventilatory setting and treated with antibiotics
from date of randomization up to 4 months of age
Development of Bronchopulmonary Dysplasia ≥ Moderate
Tidsramme: up to 4 months of age
up to 4 months of age
Development of Intraventricular Hemorrhage ≥ Grade 3
Tidsramme: up to 4 months of age
up to 4 months of age
In-hospital Death
Tidsramme: up to 4 months of age
up to 4 months of age
Development of Adverse Effects
Tidsramme: from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age

category of adverse effects

  1. general - fever or hypothermia, rash
  2. respiratory & cardiovascular - apnea, tachypnea, desaturation, hypotension, bradycardia, tachycardia
  3. gastrointestinal - abdominal distension, bilious gastric remain, vomiting, bloody stool, necrotizing enterocolitis
  4. renal - oliguria (urine output < 1.0cc/kg/day)
  5. laboratory - hypo-/hyper-natremia, acidosis, hypercarbia
from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age

Samarbejdspartnere og efterforskere

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

Sponsor

Seoul National University 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. januar 2012

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

6. januar 2012

Først indsendt, der opfyldte QC-kriterier

15. februar 2012

Først opslået (Skøn)

20. februar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. august 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. august 2014

Sidst verificeret

1. august 2014

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • OAC-01-ELGAN

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 .

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