Chlorhexidine Skin Application for Prevention of Infection in Infants Weighing <1500 g at Birth (CAPS)
Whole Body Cleansing With 0.25% Chlorhexidine at Birth for Prevention of Sepsis in Infants <1500 g: a Multi-center, Blinded, Randomized Trial
調査の概要
詳細な説明
Background
Infants weighing <1500 g at birth infants are more prone to acquire infections, often through their immature skin which serve as a portal of entry for invasive pathogens. Skin application of antiseptics such as chlorhexidine may reduce infections in these infants. However, there is a paucity of data on the safety and efficacy of such intervention in these infants.
Hypothesis:
Among hospitalized very low birth weight (VLBW; <1500 g) neonates, single whole body skin cleansing with 0.25% chlorhexidine within 6 hours after birth would reduce the incidence of sepsis in the first seven days of life from 25% to 17.5% (relative reduction of 30%) when compared to skin cleansing with sterile water
Objectives:
Primary- To evaluate the effect of whole body skin cleansing with 0.25% chlorhexidine (single application, at birth) on the incidence of sepsis (culture positive or culture negative) compared to sterile water cleansing in the first week of life in VLBW infants
Secondary- to compare following outcomes in this experiment:
- Culture-confirmed sepsis within the first week of life
- Need for repeat hospital admissions within first 28 days of life
- Mortality within first 28 days of life
- Cold stress/hypothermia at 0, 5, 15 and 30 minutes of intervention
- Skin condition at 24 h of life
- Colonization rates (subset)
- Serum levels of chlorhexidine (subset)
Methods:
Eligible infants would be randomized within 6 hours of birth to either whole body skin cleansing with chlorhexidine (specially prepared wipes releasing 0.25% chlorhexidine), or sterile water (placebo). The research staff would collect the baseline data, record the axillary temperature and assess the skin condition using the Newborn Skin Condition Scoring (NSCS)score. The research team would follow the infants for development of sepsis and other outcomes. The infants would be subjected to detailed sepsis work up on clinical suspicion of sepsis, until 28 days of life.
Sepsis would be defined based on combination of clinical course, indirect markers, bacterial culture results and antibiotic treatment status.
研究の種類
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
-
-
Delhi
-
New Delhi、Delhi、インド、110029
- All India Institute of Medical Sciences
-
New Delhi、Delhi、インド、110002
- Maulana Azad Medical College
-
New Delhi、Delhi、インド、110029
- Vardhman Medical College and Safdarjung Hospital
-
-
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:
- Birth weight less than 1500 g
Exclusion Criteria:
- Birth weight <750 g
- Major congenital malformations
- Total duration of positive pressure ventilation (PPV) > 3 mins OR chest compressions
- Shock- requiring inotropes >10 mic/kg/min
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：sterile water
sterile water wipes
|
Sterile water wipes (placebo)
|
|
実験的：0.25% chlorhexidine
0.44% chlorhexidine digluconate wipes which will release 0.25% free chlorhexidine
|
0.44% chlorhexidine di-gluconate body wipes which would release 0.25% free chlorhexidine on application
他の名前：
|
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 |
|---|---|---|
|
Sepsis within first 7 days of life
時間枠：First 7 days of life
|
Sepsis would be defined on the basis of clinical course, lab parameters including culture results and antibiotic treatment given.
|
First 7 days of life
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Readmissions & mortality rates within neonatal period
時間枠：28 days
|
The re-admissions & mortality rates within neonatal period in these infants will be prospectively recorded during hospital admission as well as follow up.
The follow up includes telephonic contact as well as home visits and verbal autopsy in cases of deaths at home.
|
28 days
|
|
Body temperature at 0, 5, 15, 30 minutes after application
時間枠：30 minutes
|
Axillary temperature would be monitored with thermometer at above time points for full three minutes.
|
30 minutes
|
|
Skin condition
時間枠：24 ±6 hours
|
Newborn Skin Condition Score (NSCS)will be used to assess the skin condition.
|
24 ±6 hours
|
|
Skin colonization rates
時間枠：24 ±6 hours
|
In a sub-group of infants, skin swabs will be collected at baseline and 24 ±6 hours and sent to microbiology lab; colonization rates would be determined by semi-quantitative methods.
|
24 ±6 hours
|
|
Chlorhexidine percutaneous absorption
時間枠：48 ±6 hours
|
Serum chlorhexidine levels will be assayed in a sub-set to assess the extent of percutaneous absorption.
5ml of blood will be stored at -80 deg.
C till transport to the lab.
Samples will be processed in batches as per standard protocol to determine the levels.
|
48 ±6 hours
|
協力者と研究者
捜査官
- 主任研究者：Vinod K Paul, MD, PhD、All India Institute of Medical Sciences, New Delhi
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始
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。