Pacifier Use During Phototherapy in Newborns With Hyperbilirubinemia

NCT06498765 | Active Not Recruiting

• 1 other identifier: IstanbulUC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hyperbilirubinemia; It is a common condition that usually occurs physiologically in newborns. Phototherapy is used in the treatment of hyperbilirubinemia. Babies cry while receiving phototherapy, the mother's inability to hold her baby in her arms, her inability to breastfeed, and the invasive procedures (bloodletting) stress the baby. Pacifiers are used among individualized developmental care practices to calm the baby and reduce stress. Another benefit of pacifiers for the baby is on the gastrointestinal system. Non-nutritive sucking stimulates oro-motor development, facilitates the development of sucking behavior and facilitates digestion in enteral feeding. Considering all these benefits, this study aimed to determine the effect of pacifier use during phototherapy on stress and bilirubin levels in newborns with hyperbilirubinemia.

Conditions

Newborn Jaundice; Pacifier

Keywords

newborn; pacifier; stress; bilirubinemia; phototherapy

Outcome Measures

Primary Outcomes (5)

• Heart rate peak

  The heart rate of the baby receiving phototherapy was measured with a pulse oximeter device attached to the baby's wrist. The evaluation will be done while the baby is in the mother's arms, 5 minutes after being placed on the phototherapy bed, and at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st and 24th hours after being placed on the phototherapy bed.

  mother's arms, 5 minutes after the baby is placed in the phototherapy bed, 5 minutes after the baby is placed in the phototherapy bed at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.

• Oxygen saturation

  The oxygen saturation of the baby receiving phototherapy was measured with a pulse oximeter device attached to the baby's wrist. The evaluation will be done while the baby is in the mother's arms, 5 minutes after being placed on the phototherapy bed, and at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st and 24th hours after being placed on the phototherapy bed.

  mother's arms, 5 minutes after the baby is placed in the phototherapy bed, 5 minutes after the baby is placed in the phototherapy bed at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.

• Bowel sounds

  The bowel sounds of the baby receiving phototherapy was measured with a pulse oximeter device attached to the baby's wrist.The evaluation will be done while the baby is in the mother's arms, 5 minutes after being placed on the phototherapy bed, and at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st and 24th hours after being placed on the phototherapy bed.

  mother's arms, 5 minutes after the baby is placed in the phototherapy bed, 5 minutes after the baby is placed in the phototherapy bed at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.

• Stress level

  Stress level in babies is evaluated with the "Newborn Stress Scale", whose Cronbach's alpha coefficient is between 0.65-0.81. The scale is a 3-point Likert type with a total of 24 items consisting of 8 sub-dimensions: facial expression, body color, respiration, activity level, consolability, muscle tone, extremities and posture. The items in the scale are graded according to the stress level and classified into 8 subgroups. Each subgroup is evaluated between 0-2 points, and a minimum of 0 and a maximum of 16 points are obtained from the scale. A score of 0 from the baby indicates that the baby's condition is stable and balanced. A high total score on the scale indicates that the baby's stress level is high. The evaluation will be done while the baby is in the mother's arms, 5 minutes after being placed on the phototherapy bed, and at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st and 24th hours after being placed on the phototherapy bed.

  mother's arms, 5 minutes after the baby is placed in the phototherapy bed, 5 minutes after the baby is placed in the phototherapy bed at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.

• Blood bilirubin level

  The blood bilirubin level of all babies observed for 24 hours, measured in line with the clinical routine, was recorded.

  18th and 24th hours

Study Arms (2)

Experimental group

EXPERIMENTAL

The newborns in the experimental group were given a pacifier.

Other: Pacifier Use

Control group

NO INTERVENTION

The newborns in the control group were not given a pacifier.

Interventions

Pacifier Use OTHER

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.

Experimental group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Term newborns
• 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

You may not qualify if:

• Newborns receiving other treatments along with phototherapy
• Newborns with a diagnosis other than hyperbilirubinemia
• Newborns using antibiotics
• Babies fed with formula milk or bottle
• Babies diagnosed with pathological Hyperbilirubinemia

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Istanbul University Cerrahpaşa

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (14)

• 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.

  PMID: 21263210 BACKGROUND

• Chey WY, Lee KY. Motilin. Clin Gastroenterol. 1980 Sep;9(3):645-56. No abstract available.

  PMID: 7000397 BACKGROUND

• Ceylan SS, Bolısık B. Examining the psychometric properties of the neonatal stress scale. Acıbadem University Journal of Health Sciences. 2017; (2):97-103.

  BACKGROUND

• 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.

  PMID: 27699765 BACKGROUND

• 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.

  PMID: 33422394 BACKGROUND

• 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.

  PMID: 30817090 BACKGROUND

• 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.

  PMID: 382069 BACKGROUND

• 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.

  PMID: 17694238 BACKGROUND

• 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.

  PMID: 28449646 BACKGROUND

• 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.

  PMID: 29240507 BACKGROUND

• 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.

  PMID: 23727630 BACKGROUND

• 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.

  PMID: 30979682 BACKGROUND

• 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.

  PMID: 2899621 BACKGROUND

• 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].

  BACKGROUND

MeSH Terms

Conditions

Jaundice, Neonatal; Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahu Pınar TURAN

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 12, 2024
• Study Start: June 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: February 1, 2025
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)