The Effect of Breast Milk Smell on Nutrition in Preterms
8 de abril de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
56
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Sibel Kucukoglu, PhD
- Número de teléfono: 30789 +903322230789
- Correo electrónico: s_nadaroglu@hotmail.com
Ubicaciones de estudio
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Konya, Pavo, 42100
- Reclutamiento
- Sibel Küçükoğlu
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Contacto:
- Sibel Kucukoglu, PhD
- Número de teléfono: +903322410041
- Correo electrónico: s_nadaroglu@hotmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
6 meses a 8 meses (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Newborn Information Form
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Abdominal Perfusion and Distension Follow-Up Form
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Sibel Kucukoglu, PhD, Selcuk University
- Silla de estudio: Adalet Yucel, Master Student, Selcuk University
- Director de estudio: Hanifi Soylu, PhD, Selcuk University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de diciembre de 2020
Finalización primaria (Anticipado)
30 de junio de 2021
Finalización del estudio (Anticipado)
30 de septiembre de 2021
Fechas de registro del estudio
Enviado por primera vez
8 de abril de 2021
Primero enviado que cumplió con los criterios de control de calidad
8 de abril de 2021
Publicado por primera vez (Actual)
13 de abril de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de abril de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
8 de abril de 2021
Última verificación
1 de abril de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SelcukUAdlt42
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Descripción del plan IPD
It will be shared after the article is published.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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