- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03192241
PUMP (Providing the Underprivileged With Manual Pumps): An RCT (PUMP)
PUMP (Providing the Underprivileged With Manual Pumps): A Randomized Controlled Trial
The primary objective of this study is to pilot an intervention of providing manual breast pumps at hospital discharge to low-income, first-time mothers and to generate initial estimates of the effect of this intervention on exclusive breastfeeding rates at 3 months (12 weeks). In this pilot study, we will compare receipt of a breast pump and brief instructions of its use to the active control of receipt of a children's book and brief instructions about reading with baby. As a secondary objective, we will investigate mothers' attitudes and opinions about the manual breast pump intervention with the goal of fine-tuning it to best fit mothers' needs before a larger, multi-center trial. To support our objectives, we will examine the following specific aims:
To test the intervention of providing low-income, first time mothers with a manual breast pump at hospital discharge on exclusive breastfeeding rates at 12 weeks.
Hypothesis: Among low-income first-time mothers, receipt of a manual breast pump at hospital discharge will lead to improved exclusive breastfeeding rates at 12 weeks postpartum compared to receipt of a children's book.
- To use qualitative methods to determine best practices associated with successful implementation of a breast pump intervention to improve breastfeeding rates among low-income, first-time mothers.
- To test the effect of receiving a children's board book during the birth hospitalization on parents reading to the baby at 3 months (12 weeks).
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
-
Sacramento, California, Förenta staterna, 95817
- University of California Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- WIC-eligibility (income below 185% the federal poverty line)
- liveborn infant
- in the well newborn nursery
- 12-96 hours of age
- infant is breastfeeding
Exclusion Criteria:
- maternal age <18 years
- maternal incarceration
- mother does not speak or read in English
- infant is a twin or higher level multiple
- infant has cleft lip and palate or a known syndrome
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Pump
Mothers provided with a manual breast pump
|
Intervention is providing mothers with a manual breast pump and instructions for when it could be used.
|
Aktiv komparator: book
Mothers provided with a children's book
|
Active control intervention is providing mother's with a children's book and information about reading to baby.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Exclusive breastfeeding at 12 weeks
Tidsram: 12 weeks
|
Infant has had no food or drink other than breast milk in the last 24 hours
|
12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Exclusive breastfeeding through 12 weeks
Tidsram: 12 weeks
|
Infant has had no food or drink other than breast milk in their lifetime as measured at 12 weeks
|
12 weeks
|
Reading to baby at 12 weeks
Tidsram: 12 weeks
|
Did parent read to baby in the last 24 hours & in the last week
|
12 weeks
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Exclusive breastfeeding at 6 weeks
Tidsram: 6 weeks
|
Infant has had no food or drink other than breast milk in the last 24 hours
|
6 weeks
|
Any breastfeeding at 12 weeks
Tidsram: 12 weeks
|
Infant has taken in breast milk in the last 24 hours
|
12 weeks
|
Any breastfeeding at 6 weeks
Tidsram: 6 weeks
|
Infant has taken in breast milk in the last 24 hours
|
6 weeks
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Laura R Kair, MD, University of California, Davis
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 1051735
- 20170959 (Annan identifierare: UC Davis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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