Impact of Intermittent Kangaroo Mother Care Versus Conventional Care Method on Vital Sign and Arterial Oxygen Saturation in Preterm Hospitalized in Neonatal Intensive Care Unit
Impact of Intermittent Kangaroo Mother Care Versus Conventional Care Method on Vital Signs and Arterial Oxygen Saturation in Preterm Hospitalized in Neonatal Intensive Care Unit : A Randomized Controlled Trail
調査の概要
詳細な説明
The mother and baby will be supported by a nurse and researcher. Hence, the study group mothers will be trained properly, and the required information and explanations along with displaying the video description about the KMC method will be provided for them, and the KMC will apply to their newborns.
Thus, the naked newborn, only wearing diaper and cap, was placed in a straight state between the mother's breasts and supported by a cloth bag. The caring is performed for 3 consecutive days, three times a day and each time for 2-h.
The procedure will be conducted for all samples by the head nurse and with the researcher's presence and monitoring in the morning shift, and the mothers should be supported and encouraged during the caring process. The changes in pulse ,respiration, temperature, and arterial oxygen saturation rate of the study group is controlled and recorded during the care process, at 60 min after starting the procedure and at the end of caring process before returning the newborn to the incubator. The mentioned items in the control group (conventional incubator care) should also measure and recorded simultaneously with the study group. The pulse oximetry in NICU used to measure the arterial oxygen saturation rate, and a mercury thermometer was used to measure the temperature with an auxiliary approach for 3 min. To maintain the reliability of the instrument during the research, the same pulse oximetry device and monitoring system will be applied to newborns in the same situation. The pulse oximetry probe will be taped to the toe of the left foot of all newborns
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Dr Maimoona Saeed, MBBS
- 電話番号:00923165415720
- メール:dr.maimoona@live.com
研究連絡先のバックアップ
- 名前:Dr Syeda Shireen Gul, MBBS,FCPS
- 電話番号:00923002263969
- メール:syedashireengul@gmail.com
研究場所
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Islamabad、パキスタン、46000
- 募集
- Pakistan Institute of Medical Sciences
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主任研究者:
- Dr Maimoona Saeed, MBBS
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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 between 1200 to 1800 gram Gestational age 28 weeks to 36+6 weeks Clinically stable Off oxygen support Hemodynamically stable baby No surgery performed on baby No cardiac ,nervous system problems
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Exclusion Criteria:
Extreme preterm<28 weeks Hemodynamically unstable Underlying cardiac problems Surgical problems Those who do not give consent Unwell or hospitalized mother who is bed bound problems Gestational age 37 weeks or >37 weeks
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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:支持療法
- 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 |
|---|---|
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実験的:Kangaroo mother care
To see the impact of intermittent kangaroo mother care on temperature ,oxygen saturation and heart rate.
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Skin to skin contact between mother and preterm newborn between gestational age 28 weeks to 36+6 weeks for three sessions per day ,each contact session of two hours .
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介入なし:standard of care
To observe temperature ,oxygen saturation and heart rate in preterm neonates not given kangaroo care
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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 |
|---|---|---|
|
Temperature
時間枠:2 hours
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To measure temperature difference in babies provided with kangaroo mother care vs incubator care
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2 hours
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Heart rate
時間枠:2 hours
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To measure heart rate variations in babies provided with kangaroo mother care vs incubator care
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2 hours
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Oxygen Saturation
時間枠:2 hours
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To measure oxygen saturation in babies provided with kangaroo mother care vs
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2 hours
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協力者と研究者
協力者
捜査官
- 主任研究者:Dr Maimoona Saeed, MBBS、Shaheed Zulfiqar Ali Bhutto Medical University
- スタディチェア:Dr Fibhaa Syed, MBBS,FCPS、Shaheed Zulfiqar Ali Bhutto Medical University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
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。