Promoting Lactation Education, Access, and Support Efforts for Preterm Infants (PLEASE)
12. juni 2018 opdateret af: Medical University of South Carolina
The purpose of this study is to determine whether a post-hospital discharge lactation support system increases preterm infant intake of mother's milk.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Preterm infants have barriers to successful breastfeeding that include oral feeding immaturity and high nutritional needs.
Therefore, successful preterm infant breastfeeding requires increased counseling and equipment support compared to full-term infant breastfeeding.
Inpatient preterm infant care has responded to these barriers, with specialized preterm infant lactation support.
Unfortunately, for preterm infants, the onset of feeding maturity often coincides with hospital discharge and, therefore, inpatient, specialized lactation support ends just as the infant initiates nutritive feeding at the breast.
Therefore, the success of preterm infant breastfeeding relies on the home environment and the community pediatric caregivers.
A program has been created to provide this specialized preterm infant/mother outpatient lactation support.
The program includes in-home availability of a hospital-grade electric pump and an infant weigh scale and pediatric clinic-based lactation counseling support.
Fourteen pediatric practices are included in this study.
Seven practices were randomized to intervention and seven were randomized to be controls.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
70
Fase
- Ikke anvendelig
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:
- Any infant discharge to home from the Medical University of South Carolina neonatal services
- Born <35 weeks' gestation
- Mother providing her milk and plans to continue providing her milk for at least 6 months
- The infant's post-discharge pediatric clinic identified by mother as one involved in the study
- The eligible twin will be the first twin discharged from the hospital or, if discharge occurs simultaneously, the infant identified in the hospital as "twin A" will be eligible.
Exclusion Criteria:
- Infants with major congenital anomalies
- Infants with anomalies affecting oral intake
- Infants receiving tube feeds at hospital discharge
- Infants receiving parenteral nutrition at hospital discharge
- Triplet or greater pregnancies
- Twin of the one enrolled twin will not be eligible.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Intervention
For infants receiving pediatric care at one of the seven intervention practices, mothers will receive the Specialized Preterm Infant/Mother Dyad Lactation Support which includes home equipment and pediatric clinic-lactation support to support lactation for four months post-hospital discharge.
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Mother will receive home equipment and pediatric clinic lactation support.
|
|
Ingen indgriben: Control
For infants receiving pediatric care at one of the seven control practices, mothers will receive standard support.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Preterm infant intake of mother's milk post-hospital discharge measured by survey.
Tidsramme: 4 months
|
4 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Preterm infant breastfeeding post-hospital discharge measured by survey.
Tidsramme: 4 months
|
4 months
|
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Sustaining preterm infant mother's milk intake post-hospital discharge measured by survey.
Tidsramme: 6 months
|
6 months
|
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Preterm infant growth post-hospital discharge collected from pediatric clinic medical record.
Tidsramme: 6 months
|
6 months
|
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Preterm infant re-hospitalization post-hospital discharge collected from pediatric clinic medical record.
Tidsramme: 6 months
|
6 months
|
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Preterm infant respiratory illness events post-hospital discharge collected from pediatric clinic medical record.
Tidsramme: 6 months
|
6 months
|
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Preterm infant gastrointestinal illness events post-hospital discharge collected from pediatric clinic medical record.
Tidsramme: 6 months
|
6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Sarah N Taylor, MD, MSCR, Medical University of South Carolina
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. december 2014
Primær færdiggørelse (Faktiske)
1. februar 2018
Studieafslutning (Faktiske)
1. april 2018
Datoer for studieregistrering
Først indsendt
15. januar 2015
Først indsendt, der opfyldte QC-kriterier
23. januar 2015
Først opslået (Skøn)
29. januar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. juni 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juni 2018
Sidst verificeret
1. juni 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- HR#27878
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 .