The Effect of Breast Milk Smell on Nutrition in Preterms
2021年4月8日 更新者：Sibel Küçükoğlu、Selcuk University
The Effect of Breast Milk Smell on Early Feeding Cues, Transition Period to Oral Nutrition and Abdominal Perfusion in Preterm Newborns
The study was planned to determine the effect of breast milk odor applied during gavage feeding on early feeding cues of preterm newborns, the transition time to oral feeding and abdominal perfusion.
調査の概要
詳細な説明
It is known that nutrient odors stimulate the initiation of digestion.
However, in preterm newborns who are fed by gavage or parenterally, exposure to the nutrient smell that initiates digestion disappears.
For this reason, it is known that odor stimulation is applied to preterm newborns to improve nutrition.
It is known that fragrances such as fragrant essential oils, the smell of breast milk, and amniotic fluid have positive effects such as shortening the transition time to oral feeding in preterm newborns, increasing nutritional tolerance and weight gain, increasing hunger symptoms, providing analgesic effect in painful procedures, and reducing hospital stay.
However, no study was found to jointly evaluate the effect of odor stimulation with breast milk on early nutritional cues, transition time to oral nutrition and abdominal perfusion in preterm newborns.
研究の種類
介入
入学 (予想される)
56
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Sibel Kucukoglu, PhD
- 電話番号：30789 +903322230789
- メール：s_nadaroglu@hotmail.com
研究場所
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Konya、七面鳥、42100
- 募集
- Sibel Küçükoğlu
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コンタクト：
- Sibel Kucukoglu, PhD
- 電話番号：+903322410041
- メール：s_nadaroglu@hotmail.com
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
6ヶ月～8ヶ月 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Born at 28-36 weeks of PW
- Birth weight >1000 gr
- 1. and 5. Apgar score average per minute ≥ 6
- Gavage method used in nutrition
- Intermittent infusion method used in nutrition,
- Not receiving mechanical ventilation / CPAP support,
- No medication or treatment is administered by the nasal route,
- Without nasal obstruction,
- Have not received any established medical diagnosis
Exclusion Criteria:
- Drugs that affect gastrointestinal function (drugs that facilitate gastric emptying and gastrointestinal passage of nutrients by increasing gastrointestinal tract motility, and drugs that reduce gastrointestinal tract motility)
- Newborns without breast milk
- Continuous infusion or parenteral feeding method is used in nutrition
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：独身
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：Experimental Group: Olfactory stimulation group
Preterm newborns in the initiative group were sniffed the smell of breast milk before and during feeding, except for routine application
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Newborns in the experimental group will be given the smell of breast milk during 3 consecutive feedings and for 3 days in the morning.
Smell stimulation will be started 1 minute before gavage feeding and the application of breast milk odor will continue until the feeding ends.
A hand-cleaning researcher will drip 15 drops of breast milk on sterile gauze to apply the smell of breast milk.
Sterile gauze dripped with breast milk will be placed as close to the newborn's nose as possible and not in contact with the newborn's skin.
After the feeding of the newborn is completed, the application of the smell of breast milk will be terminated and the gauze will be removed from the incubator.
A new sterile gauze will be used for each feeding, and these processes will be repeated with each smell stimulation for three days.
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介入なし：Control Group
Premature newborns in the control group feeds gavage according to the routine of the clinic, and no attempt will be made during feeding.
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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 |
|---|---|---|
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Newborn Information Form
時間枠：First measurement, 5 minutes
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It is a form prepared by researchers in accordance with the literature (Yildiz ve ark.
2011, Pillai ve ark.
2018, Schriever ve ark.
2018, Neal-Kluever ve ark.
2019).
In the form; gender of the baby, date of birth, method of birth, gestational week at birth, average apgar score (1. and 5. in minutes), birth weight, postnatal age, duration of transition to oral nutrition, daily body weight, nutrition frequency, amount of nutrition, food type, breast milk type, daily vomiting frequency and daily defecation frequency are information.
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First measurement, 5 minutes
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Abdominal Perfusion and Distension Follow-Up Form
時間枠：Before 1 minute from feeding
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It is a form that contains information about abdominal perfusion level developed by researchers in accordance with the literature (Gay ve ark.
2011, Gillam-Krakauer ve ark.
2013, Thomas ve ark.
2018).
Near Infrared Spectroscopy (NIRS) is a noninvasive device used in routine of neonatal intensive care unit and will be used in this study to determine the abdominal perfusion of the baby.
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Before 1 minute from feeding
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Early Feeding Tips Tracking Form
時間枠：Before 1 minute from feeding
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The form developed by the researchers in line with the literature includes the physiological and behavioral hunger symptoms of the baby, which are accepted as criteria for starting oral feeding in babies and maintaining oral nutrition successfully and reliably (Kirk, Alder ve King 2007, Ludwig ve Waitzman 2007, White ve Parnell 2013, Holloway 2014, Lubbe 2018).
The form consists of 9 items, and the answers to the items are in the form of Yes / No. Evaluation of the items in the form will be done simultaneously and separately by two observers (researcher and clinical nurse) right after the babies begin to feed, and interobserver agreement will be evaluated in order to test the reliability of the form.
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Before 1 minute from feeding
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Abdominal Perfusion and Distension Follow-Up Form
時間枠：The second measurement is 10, 30, 60 and 120 after feeding is completed. minutes.
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It is a form that contains information about abdominal perfusion level developed by researchers in accordance with the literature (Gay ve ark.
2011, Gillam-Krakauer ve ark.
2013, Thomas ve ark.
2018).
Near Infrared Spectroscopy (NIRS) is a noninvasive device used in routine of neonatal intensive care unit and will be used in this study to determine the abdominal perfusion of the baby.
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The second measurement is 10, 30, 60 and 120 after feeding is completed. minutes.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Sibel Kucukoglu, PhD、Selcuk University
- スタディチェア：Adalet Yucel, Master Student、Selcuk University
- スタディディレクター：Hanifi Soylu, PhD、Selcuk University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Gay AN, Lazar DA, Stoll B, Naik-Mathuria B, Mushin OP, Rodriguez MA, Burrin DG, Olutoye OO. Near-infrared spectroscopy measurement of abdominal tissue oxygenation is a useful indicator of intestinal blood flow and necrotizing enterocolitis in premature piglets. J Pediatr Surg. 2011 Jun;46(6):1034-40. doi: 10.1016/j.jpedsurg.2011.03.025.
- Gillam-Krakauer M, Cochran CM, Slaughter JC, Polavarapu S, McElroy SJ, Hernanz-Schulman M, Engelhardt B. Correlation of abdominal rSO2 with superior mesenteric artery velocities in preterm infants. J Perinatol. 2013 Aug;33(8):609-12. doi: 10.1038/jp.2013.3. Epub 2013 Feb 7.
- Kirk AT, Alder SC, King JD. Cue-based oral feeding clinical pathway results in earlier attainment of full oral feeding in premature infants. J Perinatol. 2007 Sep;27(9):572-8. doi: 10.1038/sj.jp.7211791. Epub 2007 Jul 12.
- Neal-Kluever A, Fisher J, Grylack L, Kakiuchi-Kiyota S, Halpern W. Physiology of the Neonatal Gastrointestinal System Relevant to the Disposition of Orally Administered Medications. Drug Metab Dispos. 2019 Mar;47(3):296-313. doi: 10.1124/dmd.118.084418. Epub 2018 Dec 19.
- Pillai A, Albersheim S, Matheson J, Lalari V, Wei S, Innis SM, Elango R. Evaluation of A Concentrated Preterm Formula as a Liquid Human Milk Fortifier in Preterm Babies at Increased Risk of Feed Intolerance. Nutrients. 2018 Oct 4;10(10):1433. doi: 10.3390/nu10101433.
- Thomas S, Nesargi S, Roshan P, Raju R, Mathew S, P S, Rao S. Gastric Residual Volumes Versus Abdominal Girth Measurement in Assessment of Feed Tolerance in Preterm Neonates: A Randomized Controlled Trial. Adv Neonatal Care. 2018 Aug;18(4):E13-E19. doi: 10.1097/ANC.0000000000000532.
- Yildiz A, Arikan D, Gozum S, Tastekin A, Budancamanak I. The effect of the odor of breast milk on the time needed for transition from gavage to total oral feeding in preterm infants. J Nurs Scholarsh. 2011 Sep;43(3):265-73. doi: 10.1111/j.1547-5069.2011.01410.x. Epub 2011 Jul 25.
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2020年12月15日
一次修了 (予想される)
2021年6月30日
研究の完了 (予想される)
2021年9月30日
試験登録日
最初に提出
2021年4月8日
QC基準を満たした最初の提出物
2021年4月8日
最初の投稿 (実際)
2021年4月13日
学習記録の更新
投稿された最後の更新 (実際)
2021年4月13日
QC基準を満たした最後の更新が送信されました
2021年4月8日
最終確認日
2021年4月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- SelcukUAdlt42
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?
いいえ
IPD プランの説明
It will be shared after the article is published.
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
いいえ
米国FDA規制機器製品の研究
いいえ
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Olfactory stimulationの臨床試験
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