Pacifier Use During Phototherapy in Newborns With Hyperbilirubinemia
NCT ID: NCT06498765
Last Updated: 2024-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2023-06-01
2025-02-01
Brief Summary
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Detailed Description
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Phototherapy treatment is applied to babies diagnosed with hyperbilirubinemia by directly giving light energy to the babies. While receiving phototherapy, the baby becomes stressed due to reasons such as the mother not being able to hold her baby in her arms, not being able to breastfeed, the baby being in a different environment such as the neonatal intensive care unit, and being exposed to invasive procedures. Individualized developmental care practices accordingly, many practices are recommended in neonatal intensive care units to reduce the stress of babies. One of these practices is non-nutritive sucking. The most commonly used method for non-nutritive sucking is the use of a pacifier. It is stated that the use of pacifiers helps the baby calm down and reduces stress in neonatal intensive care units. In 1990, the World Health Organization and the United Nations International Children's Emergency Fund determined the "Ten Steps to Successful Breastfeeding" principles for the Baby-Friendly Hospital Initiative to promote and support breastfeeding. It has been noticed that in these principles rejecting the use of pacifiers, intensive care environments where the baby is stressed and situations where the mother and the baby are separated are ignored, so it has been suggested that this situation should be brought back to the agenda. In 2013, the "Ten Steps to Successful Breastfeeding" application was revised; Considering the justified reasons for the special situations in which the newborn and the mother and the baby are separated and the situations in which the baby is stressed, the newborn The use of pacifiers has been recommended in intensive care units. Considering the 24-hour treatment period during phototherapy, the baby is separated from the mother, albeit intermittently, while receiving phototherapy. In addition, the baby is in a different environment such as the neonatal intensive care unit and is exposed to invasive procedures. All of these create stress in the baby, and pacifiers are recommended for such justified reasons. The benefits of pacifier use have been proven in neonatal intensive care units, such as calming the baby, making it easier to fall asleep, and reducing pain and stress. Another benefit of non-nutritive sucking is on the gastrointestinal system. Non-nutritive sucking stimulates oro-motor development, facilitates the development of sucking behavior and facilitates digestion in enteral feeding.
A number of enzymes and hormones are involved in facilitating digestion through non-nutritive absorption. These enzymes and hormones; lingual lipase, gastrin, insulin and motilin. Experts believe that non-nutritive sucking causes this effect through vagal stimulation of the oral mucosa. It is thought that it causes the secretion of enzymes and hormones. Non-nutritive sucking in a study reported that the use of pacifiers, one of the methods, stimulates the stomach motor functions and this facilitates the digestive process through the activation of vagal mechanisms.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Experimental group
The newborns in the experimental group were given a pacifier.
Pacifier Use
The newborns in the experimental group were given a pacifier, unlike the control group. The newborns were placed in a phototherapy incubator and each time they were placed in a phototherapy incubator, the newborns were given a pacifier for an average of 5 minutes. The researcher encouraged the babies to take the pacifier.
Control group
The newborns in the control group were not given a pacifier.
No interventions assigned to this group
Interventions
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Pacifier Use
The newborns in the experimental group were given a pacifier, unlike the control group. The newborns were placed in a phototherapy incubator and each time they were placed in a phototherapy incubator, the newborns were given a pacifier for an average of 5 minutes. The researcher encouraged the babies to take the pacifier.
Eligibility Criteria
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Inclusion Criteria
* Newborns diagnosed with hyperbilirubinemia
* Babies who do not use pacifiers
* Newborns scheduled to receive phototherapy for 24 hours
* Babies of parents who agreed to participate in the study
Exclusion Criteria
* Newborns with a diagnosis other than hyperbilirubinemia
* Newborns using antibiotics
* Babies fed with formula milk or bottle
* Babies diagnosed with pathological Hyperbilirubinemia
1 Day
28 Days
ALL
Yes
Sponsors
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Hitit University
OTHER
Responsible Party
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Ahu Pınar TURAN
Principal Investigator
Principal Investigators
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Ahu Pınar TURAN
Role: PRINCIPAL_INVESTIGATOR
Istanbul University - Cerrahpasa
Locations
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Istanbul University Cerrahpaşa
Istanbul, , Turkey (Türkiye)
Countries
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References
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Chen J, Sadakata M, Ishida M, Sekizuka N, Sayama M. Baby massage ameliorates neonatal jaundice in full-term newborn infants. Tohoku J Exp Med. 2011 Feb;223(2):97-102. doi: 10.1620/tjem.223.97.
Chey WY, Lee KY. Motilin. Clin Gastroenterol. 1980 Sep;9(3):645-56. No abstract available.
Ceylan SS, Bolısık B. Examining the psychometric properties of the neonatal stress scale. Acıbadem University Journal of Health Sciences. 2017; (2):97-103.
Foster JP, Psaila K, Patterson T. Non-nutritive sucking for increasing physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev. 2016 Oct 4;10(10):CD001071. doi: 10.1002/14651858.CD001071.pub3.
Dur S, Gozen D. Nonnutritive Sucking Before Oral Feeding of Preterm Infants in Turkey: A Randomized Controlled Study. J Pediatr Nurs. 2021 May-Jun;58:e37-e43. doi: 10.1016/j.pedn.2020.12.008. Epub 2021 Jan 6.
Gozen D, Yilmaz OE, Dur S, Caglayan S, Tastekin A. Transcutaneous bilirubin levels of newborn infants performed abdominal massage: A randomized controlled trial. J Spec Pediatr Nurs. 2019 Apr;24(2):e12237. doi: 10.1111/jspn.12237. Epub 2019 Feb 28.
Hamosh M. A review. Fat digestion in the newborn: role of lingual lipase and preduodenal digestion. Pediatr Res. 1979 May;13(5 Pt 1):615-22. doi: 10.1203/00006450-197905000-00008. No abstract available.
Kundt G. A new proposal for setting parameter values in restricted randomization methods. Methods Inf Med. 2007;46(4):440-9. doi: 10.1160/me0398.
Lubbe W, Ten Ham-Baloyi W. When is the use of pacifiers justifiable in the baby-friendly hospital initiative context? A clinician's guide. BMC Pregnancy Childbirth. 2017 Apr 27;17(1):130. doi: 10.1186/s12884-017-1306-8.
Mitra S, Rennie J. Neonatal jaundice: aetiology, diagnosis and treatment. Br J Hosp Med (Lond). 2017 Dec 2;78(12):699-704. doi: 10.12968/hmed.2017.78.12.699.
Nyqvist KH, Haggkvist AP, Hansen MN, Kylberg E, Frandsen AL, Maastrup R, Ezeonodo A, Hannula L, Haiek LN; Baby-Friendly Hospital Initiative Expert Group. Expansion of the baby-friendly hospital initiative ten steps to successful breastfeeding into neonatal intensive care: expert group recommendations. J Hum Lact. 2013 Aug;29(3):300-9. doi: 10.1177/0890334413489775. Epub 2013 May 31.
Montealegre A, Charpak N, Parra A, Devia C, Coca I, Bertolotto AM. [Effectiveness and safety of two phototherapy devices for the humanised management of neonatal jaundice]. An Pediatr (Engl Ed). 2020 Feb;92(2):79-87. doi: 10.1016/j.anpedi.2019.02.008. Epub 2019 Apr 9. Spanish.
Widstrom AM, Marchini G, Matthiesen AS, Werner S, Winberg J, Uvnas-Moberg K. Nonnutritive sucking in tube-fed preterm infants: effects on gastric motility and gastric contents of somatostatin. J Pediatr Gastroenterol Nutr. 1988 Jul-Aug;7(4):517-23. doi: 10.1097/00005176-198807000-00007.
World Health Organizations. Protecting, Promoting And Supporting Breastfeeding In Facilities Providing Maternity And Newborn Services: The Revised Baby-Friendly Hospital Initiative, 2018. https://apps.who.int/iris/bitstream/handle/10665/272943/9789241513807-eng.pdf, [Access Address: 21 February 2024].
Other Identifiers
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IstanbulUC
Identifier Type: -
Identifier Source: org_study_id
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