Professional Breastfeeding Support Intervention
12. mars 2015 oppdatert av: Marie Tarrant, The University of Hong Kong
A Randomized Controlled Trial of a Professional Breastfeeding Support Intervention to Increase the Exclusivity and Duration of Breastfeeding
The investigators will conduct an early postpartum professional breastfeeding intervention to postpartum women who are intended to breastfeed newborn babies to improve breastfeeding outcomes.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The aim of this study is to determine whether early post-partum professional breastfeeding support improves breastfeeding outcomes.
The primary hypotheses are:
- Exclusive breastfeeding rates at 1, 2, and 3 months will be increased among mother-infant pairs who receive professional lactation support or telephone follow-up support (intervention groups) when compared with those who receive usual post-natal breastfeeding support (control group);
- The rate of any breastfeeding (predominant or partial) at 1, 2, and 3 months will be increased among mother-infant pairs in the intervention groups when compared with those in the control group;
The secondary hypotheses are:
- The overall duration of exclusive breastfeeding will be increased among mother-infant pairs in the intervention groups when compared with those in the control group;
- The overall duration of any breastfeeding (predominant or partial) will be increased among mother-infant pairs in the intervention groups when compared with those in the control group.
Studietype
Intervensjonell
Registrering (Faktiske)
722
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Hong Kong, Hong Kong
- Queen Mary Hospital
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Hong Kong, Hong Kong
- Princess Margaret Hospital
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Hong Kong, Hong Kong
- Kwong Wah Hospital
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Hong Kong, Hong Kong
- Pamela Youde Nethersole Eastern Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- delivers at participating trial site,
- primiparous,
- intends to breastfeed,
- 18 years of age or older,
- has singleton pregnancy,
- Cantonese speaking,
- Hong Kong resident for more than one year,
- no serious medical or obstetrical complications
Exclusion Criteria:
- < 37 weeks gestation,
- an Apgar score < 8 at five minutes,
- a birth weight < 2500 grams,
- born with any severe medical conditions or congenital malformations,
- is placed in the special care nursery for more than 48 hours after delivery,
- is placed in the intensive care nursery after delivery,
- not entitled to health benefits in Hong Kong (NEP).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Control
In-hospital usual care consists of routine intrapartum and postnatal obstetric care.
No extra intervention will be provided by research team.
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Eksperimentell: In-hospital professional support
The participants in "in-hospital professional support" arm will receive three 30-minute one-to-one hands-on breastfeeding counseling sessions during postpartum hospitalization.
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In-hospital professional lactation support will consist of two 30-minute one-to-one hands-on breastfeeding counseling sessions in first 24 hours post-partum and one further 30-minute one-to-one hands-on breastfeeding counseling session on the second day of post-partum hospitalization for a total of three 30-minute sessions.
The one-to-one sessions will focus on: (1) education and advice on correct breastfeeding positions and techniques, (2) education and advice on milk supply and how to avoid common breastfeeding problems, and (3) hands-on instruction and assistance with proper breastfeeding positioning and technique, latching on and newborn attachment to the breast, and manual expression of breast milk.
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Eksperimentell: Postpartum telephone follow-up support
Participants in "postpartum telephone follow-up support" arm will receive telephone support in the first 4 weeks postpartum.
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Postpartum telephone follow-up support will consist of telephone support 72 hours after hospital discharge and weekly for the first 4 weeks, or until weaned.
Earlier telephone contacts will focus more on breastfeeding topics.
Information will be solicited from the participants about problems or difficulties they are experiencing.
Supportive advice will be provided regarding management of breastfeeding problems, and support and encouragement for the continuation of breastfeeding.
Later contacts will focus more on advice and encouragement on breastfeeding while resuming daily activities or returning to work, nursing in public places, and expressing and storing breast milk.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Prevalence of any and exclusive breastfeeding
Tidsramme: 1 month postpartum
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Any breastfeeding rate and exclusive breastfeeding rate at 1 month postpartum
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1 month postpartum
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Prevalence of any and exclusive breastfeeding
Tidsramme: 2 months postpartum
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Any breastfeeding rate and exclusive breastfeeding rate at 2 months postpartum
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2 months postpartum
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Prevalence of any and exclusive breastfeeding
Tidsramme: 3 months postpartum
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Any breastfeeding rate and exclusive breastfeeding rate at 3 months postpartum
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3 months postpartum
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Median duration of breastfeeding
Tidsramme: 6 month postpartum
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The median duration of any breastfeeding and the median duration of exclusive breastfeeding.
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6 month postpartum
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Marie TARRANT, PhD, MPH, RN, The University of Hong Kong
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2010
Primær fullføring (Faktiske)
1. april 2012
Studiet fullført (Faktiske)
1. mars 2013
Datoer for studieregistrering
Først innsendt
6. juni 2013
Først innsendt som oppfylte QC-kriteriene
2. juli 2013
Først lagt ut (Anslag)
9. juli 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. mars 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. mars 2015
Sist bekreftet
1. mars 2015
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- PBFS-1
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .