Target Versus Standard Human Milk Fortification in Very Low Birth Weight Preterm Infants
17. marts 2016 opdateret af: Prof. Pier Mannuccio Mannucci, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is of utmost importance.
Standard fortification is the most commonly used supplementation practice but it does not consider the native variability of human milk.
Data on efficacy and safety of prolonged target fortification are scarce.
The investigators performed a prospective interventional study in VLBW preterm infants, exclusively fed with human milk, to test efficacy and metabolic safety of target fortification in these preterm infants.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is of utmost importance.
Fortified human milk is the goal for preterm infants' nutrition.
Standard fortification is the most commonly used and safe supplementation practice but it does not consider the native variability of human milk.
Data on efficacy and safety of prolonged target fortification are scarce.
Prospective interventional study was conducted in VLBW preterm infants, exclusively fed with human milk.
Twenty-four hour collected pools of human milk were analyzed and targeted human milk fortification was performed during hospitalization.
Weekly growth and daily growth velocity were compared with that of an historical group of VLBW preterm infants that had received standard fortified human milk.
Osmolality, metabolic and gastrointestinal tolerance were monitored.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
10
Fase
- Tidlig fase 1
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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion criteria:
- Birth weight < 1500 grams
- Gestational age < 32 weeks
- Birth weight > 10th percentile according to Fenton' growth chart
- Exclusively breast feeding during the entire hospital stay
Exclusion criteria:
- Presence of congenital malformations that could affect growth (congenital diseases, chromosomal abnormalities, chronic lung disease, severe brain disease, severe metabolic, cardiac or gastrointestinal diseases)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Intervention group
In the intervention group VLBW infants were fed target fortified human milk Growth and safety were compared to a historical group of VLBW infants fed with standard fortified human milk
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Daily growth velocity (g/kg/day)
Tidsramme: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
|
From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
weekly weight increase (g/week)
Tidsramme: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
|
From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
|
|
weekly length increase (cm/week)
Tidsramme: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
|
From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
|
|
head circumference increase (cm/week)
Tidsramme: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
|
From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
osmolality of fortified human milk
Tidsramme: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
|
From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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.
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. oktober 2014
Primær færdiggørelse (Faktiske)
1. marts 2015
Datoer for studieregistrering
Først indsendt
7. marts 2016
Først indsendt, der opfyldte QC-kriterier
17. marts 2016
Først opslået (Skøn)
23. marts 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
23. marts 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. marts 2016
Sidst verificeret
1. marts 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Target HM fortification
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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Kliniske forsøg med Addition of human milk fortifiers according to human milk analysis
-
The Hospital for Sick ChildrenWorld Health OrganizationAfsluttet