Impact of Chlorhexidine Cleansing on Bacteria Colonizing the Umbilical Cord of Infants in Bangladesh
Bacterial Colonization of the Neonatal Umbilical Cord and Impact of 4.0% Chlorhexidine Cleansing on the Bacteriological Profile of the Umbilical Cord of Newborns in Sylhet District, Bangladesh
Background: In developing countries, many babies are born at home and the umbilical cord commonly becomes infected during the first week after birth, and can be deadly. Cleansing of the cord with a low-cost antiseptic like chlorhexidine may reduce the risk of these infections. Little is known, however, about the frequency of chlorhexidine cleansing needed to impact upon the overall presence of bacteria on the stump, or regarding the changes in bacteria during the first week of life when most cord infections occur.
Objectives: We will describe the profile of bacteria colonizing the umbilical cord stump of infants in rural Bangladesh and examine the role of topical chlorhexidine in altering colonization and progress of infection. We will compare the overall and bacteria-specific rate of colonization of the cord stump between infants receiving chlorhexidine cleansing of their cord through the first day or first week of life. We will also quantify the relationship between colonization of the cord stump with specific pathogens and the presence and severity of signs of umbilical cord infection (pus, redness, swelling) among these newborns.
Potential Impact: More information is needed on the impact of single versus repeated applications of chlorhexidine to the cord stump, as the number of cleansing may substantially influence the feasibility of widespread scale-up in many populations. The data generated from this proposed study will guide the most appropriate design of this simple intervention and will help inform specific treatment protocols for effective management of infants with signs of umbilical cord infections.
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
参加基準
適格基準
就学可能な年齢
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:
- Enrolled in parent chlorhexidine cleansing trial
Exclusion Criteria:
- Not enrolled in parent trial
- First visited after 48 hours of life
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:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:A
Chlorhexidine cleansing of the cord for seven days
|
Solution (4.0%, 7.1% CHX-D)
|
実験的:B
Chlorhexidine cleansing of the cord for 1 day
|
Solution (4.0%, 7.1% CHX-D)
|
プラセボコンパレーター:C
Dry cord care, as recommended by WHO
|
Educational messages regarding clean cord care
|
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 |
---|---|---|
Colonization at Day 1 Swab
時間枠:First week of life
|
Was the swab collected on the day 1 visit (usually within 24 hours of birth) positive for any organism?
If so, this is defined as positive.
|
First week of life
|
Colonization at Day 3 Swab
時間枠:First Week of Life
|
Were any organisms found on the swab collected on at Day 03
|
First Week of Life
|
Colonization at Day 7 Swab
時間枠:First Week of Life
|
Were any organisms found on the swab collected on the day 07 visit?
|
First Week of Life
|
協力者と研究者
捜査官
- スタディディレクター:Luke C Mullany, PhD、Johns Hopkins Bloomberg School of Public Health
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。
Chlorhexidine 4.0%の臨床試験
-
Thomas Jefferson University招待による登録
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Oslo University HospitalUniversity Medical Center Groningen; National Health Service, United Kingdomわからない
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Washington University School of MedicineVarian Medical Systems募集
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University Hospital, MontpellierPediatric and Congenital Cardiology Department of Necker-enfant malades University Hospital...完了
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Flanders Medical Research ProgramAngioScore, Inc.完了