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.
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
56
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Sibel Kucukoglu, PhD
- 电话号码：30789 +903322230789
- 邮箱：s_nadaroglu@hotmail.com
学习地点
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Konya、火鸡、42100
- 招聘中
- Sibel Küçükoğlu
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接触：
- Sibel Kucukoglu, PhD
- 电话号码：+903322410041
- 邮箱：s_nadaroglu@hotmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
6个月 至 8个月 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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无干预：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Newborn Information Form
大体时间：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
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Abdominal Perfusion and Distension Follow-Up Form
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Sibel Kucukoglu, PhD、Selcuk University
- 学习椅：Adalet Yucel, Master Student、Selcuk University
- 研究主任：Hanifi Soylu, PhD、Selcuk University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年12月15日
初级完成 (预期的)
2021年6月30日
研究完成 (预期的)
2021年9月30日
研究注册日期
首次提交
2021年4月8日
首先提交符合 QC 标准的
2021年4月8日
首次发布 (实际的)
2021年4月13日
研究记录更新
最后更新发布 (实际的)
2021年4月13日
上次提交的符合 QC 标准的更新
2021年4月8日
最后验证
2021年4月1日
更多信息
与本研究相关的术语
其他研究编号
- SelcukUAdlt42
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计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
It will be shared after the article is published.
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