Newborn JaundiceNCT06498765
Pacifier Use During Phototherapy in Newborns With Hyperbilirubinemia
A study testing Pacifier Use in people with Newborn Jaundice and Pacifier, run by Hitit University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Newborn Jaundice, Pacifier
- What is being tested?
- Pacifier Use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpaşa
Istanbul, 34000
About this study
Official title: Effect of Pacifier Use During Phototherapy on Stress and Bilirubin Level in Newborns With Hyperbilirubinemia
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.
Read the detailed description
After birth, fetal erythrocytes in the newborn are rapidly destroyed and the total bilirubin level increases, resulting in hyperbilirubinemia. Hyperbilirubinemia; although it is a common condition that usually occurs physiologically in newborns, it causes neurological dysfunction in the newborn when it reaches high bilirubin levels. Therefore, follow-up and treatment are important. One of the treatment approaches for hyperbilirubinemia is phototherapy.
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
- Newborn Jaundice, Pacifier
- Being tested
- Pacifier Use
- Keywords
- newborn, pacifier, stress, bilirubinemia, phototherapy
- Medical subject headings
- Jaundice, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacifier UseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The newborns in the experimental group were given a pacifier. Receives: Other: Pacifier Use |
| Control group | No intervention | The newborns in the control group were not given a pacifier. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18th and 24th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Jun 2023
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Newborn JaundiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahu Pınar TURAN, Hitit University
- Investigators
- Ahu Pınar TURAN, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498765
- Sponsor's protocol ID
- IstanbulUC
- Status last verified
- Aug 2024
- First submitted
- 29 Jun 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I Don't Plan to Share IPD
Publications
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.
PubMed 21263210Chey WY, Lee KY. Motilin. Clin Gastroenterol. 1980 Sep;9(3):645-56. No abstract available.
PubMed 7000397Ceylan 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.
PubMed 27699765Dur 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.
PubMed 33422394Gozen 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.
PubMed 30817090Hamosh 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.
PubMed 382069Kundt G. A new proposal for setting parameter values in restricted randomization methods. Methods Inf Med. 2007;46(4):440-9. doi: 10.1160/me0398.
PubMed 17694238Lubbe 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.
PubMed 28449646Mitra 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.
PubMed 29240507Nyqvist 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.
PubMed 23727630Montealegre 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.
PubMed 30979682Widstrom 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.
PubMed 2899621World 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].
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pacifier Use During Phototherapy on Stress and Bilirubin Level in Newborns With Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT06498765
- Acronym / sponsor ID
- IstanbulUC
- Conditions
- Newborn Jaundice, Pacifier
- Keywords
- newborn, pacifier, stress, bilirubinemia, phototherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After birth, fetal erythrocytes in the newborn are rapidly destroyed and the total bilirubin level increases, resulting in hyperbilirubinemia. Hyperbilirubinemia; although it is a common condition that usually occurs physiologically in newborns, it causes neurological dysfunction in the newborn when it reaches high bilirubin levels. Therefore, follow-up and treatment are important. One of the treatment approaches for hyperbilirubinemia is phototherapy.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Pacifier UseThe newborns in the experimental group were given a pacifier. |
| Control group | No intervention | –The newborns in the control group were not given a pacifier. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacifier UseThe 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. | Other | Experimental group |
Primary outcome
Heart rate peak
Time frame: 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.
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.
Oxygen saturation
Time frame: 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.
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.
Bowel sounds
Time frame: 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.
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.
Stress level
Time frame: 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 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.
Blood bilirubin level
Time frame: 18th and 24th hours
The blood bilirubin level of all babies observed for 24 hours, measured in line with the clinical routine, was recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Background: PubMed 21263210Chen 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.
- Background: PubMed 7000397Chey WY, Lee KY. Motilin. Clin Gastroenterol. 1980 Sep;9(3):645-56. No abstract available.
- BackgroundCeylan SS, Bolısık B. Examining the psychometric properties of the neonatal stress scale. Acıbadem University Journal of Health Sciences. 2017; (2):97-103.
- Background: PubMed 27699765Foster 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.
- Background: PubMed 33422394Dur 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.
- Background: PubMed 30817090Gozen 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.
- Background: PubMed 382069Hamosh 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.
- Background: PubMed 17694238Kundt G. A new proposal for setting parameter values in restricted randomization methods. Methods Inf Med. 2007;46(4):440-9. doi: 10.1160/me0398.
- Background: PubMed 28449646Lubbe 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.
- Background: PubMed 29240507Mitra 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.
- Background: PubMed 23727630Nyqvist 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.
- Background: PubMed 30979682Montealegre 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.
- Individual participant dataSharing planned: No. I Don't Plan to Share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahu Pınar TURAN principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacifier Use in people with Newborn Jaundice and Pacifier, run by Hitit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate peak (time frame: 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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06498765, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.