- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01404416
Effect of Antenatal Iron-contained Multiple Micronutrient Supplementation, Cesarean Delivery, and CDMR on Child Health
4. juni 2015 opdateret af: Liu Jianmeng, Peking University
Effect of Antenatal Iron-contained Multiple Micronutrient Supplementation, Cesarean Delivery, and CDMR on Child Health- A Post-trial Follow-up Chinese Study
The follow-up study was based on our previous nutritional intervention trial entitled "Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality (NCT00133744)".
We followed up all livebirths born to women of the trial to measure their height, weight, and hemoglobin and to implement a questionaire survey (including developmental milestones, disease history, breast feeding, passive smoking, et al).
We selected a sub-sample of infants to assess their IQ, emotional and behavioral problem, and language development status.
The outcomes of interest include death, body mass index, overweight/ obesity, stunting/ wasting/ thinness, anemia, developmental milestones, IQ, emotional and behavioral disorder, language developmental status, and disease history.
Other interesting exposure includes breast feeding, passive smoking, et al.
We hypothesize that intrauterine nutritional exposure has an impact on offspring's physical, mental, and language development.
We also hypothesize that cesarean delivery including CDMR has an impact on offspring's these outcomes.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The follow-up study was based on our previous nutritional intervention trial entitled "Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality (NCT00133744)".
We followed up all livebirths born to women of the trial to measure their height, weight, and hemoglobin and to implement a questionaire survey (including developmental milestones, disease history, breast feeding, passive smoking, et al).
We selected 1200 <30 months infants to assess their IQ with Bayley scale, emotional and behavioral problem with CBCL scale, and language development status with LDS scale.
We also selected 1500 >30 months children to measure their emotional and behavioral problem with CBCL scale.
The exposure groups include intrauterine nutritional exposure and cesarean delivery exposure as well as CDMR.
The outcomes of interest include death, body mass index, overweight/ obesity, stunting/ wasting/ thinness, anemia, developmental milestones, IQ, emotional and behavioral disorder, language developmental status, and disease history.
Other interesting exposure includes breast feeding, passive smoking, et al.
We hypothesize that intrauterine nutritional exposure has an impact on offspring's physical, mental, and language development.
We also hypothesize that cesarean delivery including CDMR has an impact on offspring's these outcomes.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
17000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Hebei
-
Baoding, Hebei, Kina
- Mancheng Maternal and Child Health Hospital
-
Langfang, Hebei, Kina
- Xianghe Maternal and Child Health Hospital
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Shijiazhuang, Hebei, Kina
- Yuanshi Maternal and Child Health Hospital
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Tangshan, Hebei, Kina
- Fengrun Maternal and Child Health Hospital
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Tangshan, Hebei, Kina
- Laoting Maternal and Child Health 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
1 år til 5 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
all livebirths born to women of our previous trial (NCT00133744) who were from Laoting, Fengrun, Xianghe, Mancheng, and Yuanshi counties of China.
Beskrivelse
Inclusion Criteria:
- all livebirths
Exclusion Criteria:
- died
- moved out
- refused to participate
- being incapable of participation
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
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. maj 2011
Primær færdiggørelse (Faktiske)
1. september 2011
Studieafslutning (Faktiske)
1. september 2011
Datoer for studieregistrering
Først indsendt
27. juli 2011
Først indsendt, der opfyldte QC-kriterier
27. juli 2011
Først opslået (Skøn)
28. juli 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. juni 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juni 2015
Sidst verificeret
1. juni 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 5119001
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 .