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).
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
California
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Sacramento、California、アメリカ、95817
- University of California Medical Center
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
アクティブコンパレータ：book
Mothers provided with a children's book
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Active control intervention is providing mother's with a children's book and information about reading to baby.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Exclusive breastfeeding at 12 weeks
時間枠：12 weeks
|
Infant has had no food or drink other than breast milk in the last 24 hours
|
12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Exclusive breastfeeding through 12 weeks
時間枠：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
時間枠：12 weeks
|
Did parent read to baby in the last 24 hours & in the last week
|
12 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Exclusive breastfeeding at 6 weeks
時間枠：6 weeks
|
Infant has had no food or drink other than breast milk in the last 24 hours
|
6 weeks
|
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Any breastfeeding at 12 weeks
時間枠：12 weeks
|
Infant has taken in breast milk in the last 24 hours
|
12 weeks
|
|
Any breastfeeding at 6 weeks
時間枠：6 weeks
|
Infant has taken in breast milk in the last 24 hours
|
6 weeks
|
協力者と研究者
捜査官
- 主任研究者：Laura R Kair, MD、University of California, Davis
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 1051735
- 20170959 (その他の識別子：UC Davis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Pumpの臨床試験
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Brigham and Women's HospitalCenter for Integration of Medicine & Innovative Technology; Fogarty International Clinical Research...完了
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University of Colorado, DenverChildren's Hospital Colorado; Avanos Medical; Colorado Fetal Care Center募集
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Sansum Diabetes Research InstituteNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Harvard University; Jaeb...完了
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Xeris PharmaceuticalsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Emissary International...完了
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Xeris PharmaceuticalsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完了