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Carlsen Misic, M., Eriksson, M., Normann, E., Pettersson, M., Thernström-Blomqvist, Y. & Olsson, E. (2024). Clonidine as analgesia during retinopathy of prematurity screening in preterm infants -cloROP. In: : . Paper presented at Swedish Conference on Ultra-Early Intervention, Lund, March 21, 2024.
Open this publication in new window or tab >>Clonidine as analgesia during retinopathy of prematurity screening in preterm infants -cloROP
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2024 (English)Conference paper, Oral presentation only (Refereed)
Abstract [en]

Background

Preterm infants are vulnerable and sensitive to stimuli, during their stay in neonatal intensive care they undergo frequent stressful and painful procedures. One of these painful procedures is the screening for retinopathy of prematurity, ROP. In Sweden all preterm infants born before gestation week 30 undergo ROP-screening. The screening involves regular eye examinations to detect ROP at the early stages and these examinations are both stressful and painful. Several studies have investigated different ways of pain management during eye examinations with inconsequent results. No study has investigated Clonidine as pain management during ROP-screening.  

Aim

The aim of this clinical trial is to investigate the analgesic effect of clonidine during ROP eyeexaminations.

Method

This study is a multicenter randomized controlled clinical trial with a crossover design. Infants born before gestation week 30 and therefore undergoing ROP-screening, will be eligible for inclusion in the study. Infants will be recruited from two Swedish NICUs (neonatal intensive care units). The NICUs use different examination techniques, where NICU A uses indirect ophthalmoscopy while NICU B uses RetCam. A total of 50 infants will be recruited (25 at each NICU).  During the first eye examination the infant will be randomized to either clonidine 4mcg/kg or sterile water in the equivalent dose 60 minutes before the eye examination. The order of the treatment is blinded for everyone except the nurse preparing the study solution. During the second eye examination the infant will receive the study solution, (intervention or placebo) that he/she did not receive the first time.  The primary outcome of the study is pain assessment with the Premature Infant Pain Profile – Revised. The infants´ face and monitor showing oxygen saturation and heart rate will be videorecorded to be able to assess the pain afterwards. The secondary outcome is Galvanic Skin Response where three probes are attached to the infant’s foot sole to register changes in the sweat gland activity in response to stimuli such as pain or stress. The ophthalmologist performing the eye examination will also rate how easy it was to examine the infant by marking an X on a 10cm VAS scale with “very easy to examine” on one end and “very difficult to examine” on the other end.  Data collection is ongoing with 19 infants included at the moment.  

Keywords
Pain, newborn infant, retinopathy of prematurity, screening, clonidine
National Category
Nursing Pediatrics
Research subject
Caring sciences; Pediatrics; Caring Sciences w. Medical Focus
Identifiers
urn:nbn:se:oru:diva-112514 (URN)
Conference
Swedish Conference on Ultra-Early Intervention, Lund, March 21, 2024
Available from: 2024-03-21 Created: 2024-03-21 Last updated: 2024-03-25Bibliographically approved
Pettersson, M., Eriksson, M., Albinsson, E., Odlind, A., Blomberg, K., Ryen, L. & Ohlin, A. (2023). Home phototherapy for hyperbilirubinemia in neonates: an unblinded multicentre randomised controlled trial. In: Örebro University's Nobel Day Festivities: Book of Abstracts. Paper presented at Nobel Day Festivites.
Open this publication in new window or tab >>Home phototherapy for hyperbilirubinemia in neonates: an unblinded multicentre randomised controlled trial
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2023 (English)In: Örebro University's Nobel Day Festivities: Book of Abstracts, 2023Conference paper, Oral presentation with published abstract (Refereed)
Abstract [en]

Background/Objective: The aim of this study was to assess whether home phototherapy is a safe alternative to hospital treatment.

Method: This was a randomised controlled, multicentre, trial in which term newborns with a total serum bilirubin of 300-400 μmol/ were randomized to either home phototherapy or conventional in-hospital phototherapy.The outcome measurements were parent-infant bonding, stress and measurements of safety and feasibility. A descriptive qualitative study based on interviews was performed as well as a health economic analysis.

Result: 147 patients were recruited from 6 hospitals, Results showed no difference between groups in the safety and feasibility outcomes. Parents in the intervention group had better scores on bonding and lower levels of stress. The interviews showed that parents felt secure at home. The cost per patient was €337 for home phototherapy compared with €1156 for the hospital alternative indicating average cost savings of €819 or 71% per patient.

Conclusion: Home phototherapy can be considered a safe and feasible alternative to hospital care for well selected patients. It improves bonding and stress for parents and reduces health care costs. Since the first publication from this study was published home phototherapy is now recommended by the American Academy of Pediatrics as an alternative to hospital care for patients with uncomplicated hyperbilirubinemia.

Keywords
Newborn infant, phototherapy
National Category
Pediatrics Nursing
Identifiers
urn:nbn:se:oru:diva-110073 (URN)978-91-87789-92-2 (ISBN)
Conference
Nobel Day Festivites
Available from: 2023-12-06 Created: 2023-12-06 Last updated: 2023-12-13Bibliographically approved
Pettersson, M., Eriksson, M. & Blomberg, K. (2023). Parental experiences of home phototherapy for neonatal hyperbilirubinemia. Journal of Child Health Care, 27(4), 562-573
Open this publication in new window or tab >>Parental experiences of home phototherapy for neonatal hyperbilirubinemia
2023 (English)In: Journal of Child Health Care, ISSN 1367-4935, E-ISSN 1741-2889, Vol. 27, no 4, p. 562-573Article in journal (Refereed) Published
Abstract [en]

Newborns with hyperbilirubinemia have traditionally received phototherapy in hospital. Hospital stays for infants, however, may negatively affect parent–infant bonding and induce anxiety and feelings of powerlessness in mothers. This study examined parent’s experiences of providing phototherapy to their neonates at home instead. A descriptive qualitative study based on 15 interviews (8 mothers and 7 fathers) with parents of 8 children who had been randomised to home phototherapy was conducted during spring 2018 in Örebro county, Sweden. Inductive content analysis was used. The overall experience of home phototherapy was positive, and five categories were identified describing their experiences: continuing life at home, adjusting to having a newborn, feeling secure, experiencing parenthood and accessing information. The findings support the use of home phototherapy. Parents felt secure at home with their infants and emphasised the importance of clear information and round-the-clock access to hospital staff.

Place, publisher, year, edition, pages
Sage Publications, 2023
Keywords
Hyperbilirubinemia, Neonatal, Phototherapy, Qualitative research
National Category
Pediatrics Nursing
Identifiers
urn:nbn:se:oru:diva-98249 (URN)10.1177/13674935221082404 (DOI)000780662800001 ()35341337 (PubMedID)2-s2.0-85127346083 (Scopus ID)
Note

Funding agencies:

Little Child foundation

Örebro and Uppsala regional research fund

Available from: 2022-03-27 Created: 2022-03-27 Last updated: 2024-01-12Bibliographically approved
Pettersson, M., Ryen, L., Eriksson, M. & Ohlin, A. (2023). The cost‑effectiveness of home phototherapy for hyperbilirubinemia in neonates: results from a randomized controlled trial. Scientific Reports, 13, Article ID 10727.
Open this publication in new window or tab >>The cost‑effectiveness of home phototherapy for hyperbilirubinemia in neonates: results from a randomized controlled trial
2023 (English)In: Scientific Reports, E-ISSN 2045-2322, Vol. 13, article id 10727Article in journal (Refereed) Published
Abstract [en]

This study aimed to establish the cost‑effectiveness of home phototherapy versus hospitalphototherapy treating hyperbilirubinemia in neonates more than 36 weeks. Based on clinical resultsfrom a randomised controlled trial showing that home phototherapy for hyperbilirubinemia in termneonates is as effective as hospital phototherapy, we performed a cost‑minimisation analysis toidentify the most cost‑effective alternative. We included costs for health care resource use as wellas costs for transportation in connection with re‑visits. The cost per patient was €337 for homephototherapy compared with €1156 for the hospital alternative indicating average cost savingsof €819 (95% confidence interval €613–1025) or 71% per patient. Transportation and outpatientcosts were higher in the home treatment group and hospital care costs were higher in the hospitalgroup. Sensitivity analysis shows that results are robust also when allowing for uncertainty. Homephototherapy for neonates more than 36 weeks costs less than in‑hospital phototherapy whilebeing equally effective, meaning that home phototherapy is a cost‑effective alternative to hospitaltreatment for infants with neonatal hyperbilirubinemia.

Place, publisher, year, edition, pages
Springer Nature, 2023
Keywords
Newborn, phototherapy, health economy
National Category
Pediatrics Nursing
Identifiers
urn:nbn:se:oru:diva-106875 (URN)10.1038/s41598-023-37684-y (DOI)001023060100030 ()37400561 (PubMedID)2-s2.0-85163995059 (Scopus ID)
Funder
Örebro University
Note

Funding agency:

Uppsala and Örebro regional county council

Available from: 2023-07-03 Created: 2023-07-03 Last updated: 2023-09-13Bibliographically approved
Carlsen Misic, M., Eriksson, M., Normann, E., Pettersson, M., Blomqvist, Y. & Olsson, E. (2022). Clonidine as analgesia during retinopathy of prematurity screening in preterm infants (cloROP): protocol for a randomised controlled trial. BMJ Open, 12(9), Article ID e064251.
Open this publication in new window or tab >>Clonidine as analgesia during retinopathy of prematurity screening in preterm infants (cloROP): protocol for a randomised controlled trial
Show others...
2022 (English)In: BMJ Open, E-ISSN 2044-6055, Vol. 12, no 9, article id e064251Article in journal (Refereed) Published
Abstract [en]

Introduction Preterm infants are at risk of negative consequences from stress and pain at the same time as they often are in need of intensive care that includes painful interventions. One of the frequent painful procedures preterm infants undergo is eye examination screening to detect early signs of ROP (retinopathy of prematurity). These examinations are both stressful and painful, and despite a multitude of research studies, no conclusive pain-relieving treatment has been demonstrated. The main aim of this trial is to investigate the analgesic effect of clonidine during ROP eye examinations.

Methods and analysis The planned study is a multicentre randomised controlled trial with a crossover design. Infants will be recruited from two different neonatal intensive care units (NICUs) in Sweden. Infants born before gestation week 30 (and therefore eligible for ROP screening) and cared for in either of the NICUs will be eligible for inclusion in the study. The primary outcome will be Premature Infant Pain Profile–Revised score within 30 s after starting the examination. Secondary outcomes will be changes in the galvanic skin response parameters (area small peaks, area huge peaks, peaks per second and average rise time) within 30 s after starting the eye examination, together with the number and evaluation of adverse events reported within 72 hours after the examination and the examining physician’s assessment of how easy the infant was to examine.

Ethics and dissemination Approval from the Swedish Ethical Review Authority and the Swedish Medical Products Agency has been obtained for the study. Parents of eligible infants will be getting both verbal and written information about the study including that participation is voluntary. Data will be collected and treated in accordance with the European general data protection regulations. The results will be reported on group level and published in a scientific journal.

Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2022
Keywords
Pain, newborn infant, retinopathy of prematurity, screening, clonidine
National Category
Nursing Pediatrics
Research subject
Caring Sciences w. Medical Focus
Identifiers
urn:nbn:se:oru:diva-101398 (URN)10.1136/bmjopen-2022-064251 (DOI)000859948800021 ()36137627 (PubMedID)2-s2.0-85138330802 (Scopus ID)
Projects
cloROP - Clonidine as analgesia during retinopathy of prematurity screening in preterm infants
Funder
Region Örebro County, OLL-934822
Note

Funding agency:

Lilla Barnets Fond YE1353

Available from: 2022-09-23 Created: 2022-09-23 Last updated: 2023-08-28Bibliographically approved
Pettersson, M., Eriksson, M., Odlind, A. & Ohlin, A. (2022). Home phototherapy of term neonates improves parental bonding and stress: findings from a randomised controlled trial. Acta Paediatrica, 111(4), 760-766
Open this publication in new window or tab >>Home phototherapy of term neonates improves parental bonding and stress: findings from a randomised controlled trial
2022 (English)In: Acta Paediatrica, ISSN 0803-5253, E-ISSN 1651-2227, Vol. 111, no 4, p. 760-766Article in journal (Refereed) Published
Abstract [en]

AIM: We aimed to evaluate whether in-home phototherapy for hyper bilirubinaemia could reduce the poorer parent-infant bonding and increased parental stress associated with neonatal hospital treatment.

METHODS: In this multicentre randomised controlled trial we allocated families to either home phototherapy or standard hospital care. The primary outcome was parent-infant bonding measured on the Postpartum Bonding Questionnaire directly after therapy and 4 months later. Secondary outcomes were results on four other instruments measuring parental bonding, quality of life, and mental health.

RESULTS: We randomised 78 of 147 newborn infants to intervention and 69 to the control group. No significant differences were detected in length of stay, mean bilirubin, or weight gain. Parents in the intervention group had better scores on bonding both at discharge (p = 0.034) and at 4 months (p = 0.008; effect size r = 0.2) and lower levels of stress at 4 months (p = 0.024) than controls. No statistically significant outcomes were found for the secondary outcomes.

CONCLUSION: In-home phototherapy improved bonding and reduced parental stress in comparison with usual in-hospital treatment. Caregivers should consider offering home phototherapy to families of non-immunised term infants with hyperbilirubinaemia.

Place, publisher, year, edition, pages
John Wiley & Sons, 2022
Keywords
Home phototherapy, neonatal hyperbilirubinemia, parental stress, parental-child bonding
National Category
Pediatrics
Identifiers
urn:nbn:se:oru:diva-96132 (URN)10.1111/apa.16231 (DOI)000734947800001 ()34932853 (PubMedID)2-s2.0-85122026892 (Scopus ID)
Note

Funding agency:

Uppsala and Örebro regional county council

Available from: 2021-12-22 Created: 2021-12-22 Last updated: 2023-12-08Bibliographically approved
Pettersson, M., Eriksson, M., Odlind, A. & Ohlin, A. (2022). Response to letter by Brendan O'Shea concerning "Home phototherapy of term neonates improves parental bonding and stress: Findings from a randomised controlled trial" [Letter to the editor]. Acta Paediatrica, 111(7), 1452-1453
Open this publication in new window or tab >>Response to letter by Brendan O'Shea concerning "Home phototherapy of term neonates improves parental bonding and stress: Findings from a randomised controlled trial"
2022 (English)In: Acta Paediatrica, ISSN 0803-5253, E-ISSN 1651-2227, Vol. 111, no 7, p. 1452-1453Article in journal, Letter (Other academic) Published
Place, publisher, year, edition, pages
Wiley-Blackwell Publishing Inc., 2022
National Category
Pediatrics
Identifiers
urn:nbn:se:oru:diva-97575 (URN)10.1111/apa.16293 (DOI)000758576300001 ()35170784 (PubMedID)2-s2.0-85125768225 (Scopus ID)
Available from: 2022-02-17 Created: 2022-02-17 Last updated: 2023-12-08Bibliographically approved
Pettersson, M., Eriksson, M., Odlind, A. & Ohlin, A. (2022). Response to letter by Gowda Prashanth concerning 'Randomised controlled trial of home phototherapy in term neonates: Pertinent issues' [Letter to the editor]. Acta Paediatrica, 111(7), 1456-1457
Open this publication in new window or tab >>Response to letter by Gowda Prashanth concerning 'Randomised controlled trial of home phototherapy in term neonates: Pertinent issues'
2022 (English)In: Acta Paediatrica, ISSN 0803-5253, E-ISSN 1651-2227, Vol. 111, no 7, p. 1456-1457Article in journal, Letter (Other academic) Published
Place, publisher, year, edition, pages
John Wiley & Sons, 2022
Keywords
Phototherapy, Newborn infant
National Category
Pediatrics Nursing
Identifiers
urn:nbn:se:oru:diva-98524 (URN)10.1111/apa.16350 (DOI)000782733300001 ()35388534 (PubMedID)2-s2.0-85128753256 (Scopus ID)
Available from: 2022-04-11 Created: 2022-04-11 Last updated: 2023-12-08Bibliographically approved
Pettersson, M., Eriksson, M., Albinsson, E. & Ohlin, A. (2021). Home phototherapy for hyperbilirubinemia in term neonates: a multicentre randomised controlled trial. In: : . Paper presented at Pediatric Academic Societies (PAS) 2021 Virtual, Phase I: April 30 - May 4, Phase II: May 10 - June 4, 2021 [Digital]..
Open this publication in new window or tab >>Home phototherapy for hyperbilirubinemia in term neonates: a multicentre randomised controlled trial
2021 (English)Conference paper, Oral presentation with published abstract (Refereed)
Keywords
Neonatal jaundice, Home phototherapy, Total serumbilirubin
National Category
Pediatrics Nursing
Research subject
Pediatrics; Caring Sciences w. Medical Focus
Identifiers
urn:nbn:se:oru:diva-91626 (URN)
Conference
Pediatric Academic Societies (PAS) 2021 Virtual, Phase I: April 30 - May 4, Phase II: May 10 - June 4, 2021 [Digital].
Available from: 2021-05-06 Created: 2021-05-06 Last updated: 2021-05-20Bibliographically approved
Pettersson, M., Eriksson, M., Albinsson, E. & Ohlin, A. (2021). Home phototherapy for hyperbilirubinemia in term neonates: an unblinded multicentre randomized controlled trial. European Journal of Pediatrics, 180(5), 1603-1610
Open this publication in new window or tab >>Home phototherapy for hyperbilirubinemia in term neonates: an unblinded multicentre randomized controlled trial
2021 (English)In: European Journal of Pediatrics, ISSN 0340-6199, E-ISSN 1432-1076, Vol. 180, no 5, p. 1603-1610Article in journal (Refereed) Published
Abstract [en]

The aim of this study was to assess whether home phototherapy was feasible and safe in a cohort of otherwise healthy term-born neonates who fulfilled the criteria for in-hospital phototherapy. This was a randomized controlled trial in which term newborns with a total serum bilirubin of 18–24 mg/dL (300–400 μmol) were randomized to either home phototherapy or conventional in-hospital phototherapy. The primary outcome measurements were safety and efficacy, length of stay and the number of failed treatments. The secondary outcomes were the number of blood samples and weight gain during treatment. One hundred forty-seven patients were recruited, 69 patients randomized to conventional phototherapy and 78 to home phototherapy. The results showed that no patients needed blood exchange and only 4% of the patients allocated to home phototherapy were admitted to the hospital. The duration of phototherapy, length of stay, amount of blood tests and weight change showed no statically significant differences.

Conclusion: Home phototherapy could be a safe alternative to inpatient phototherapy for otherwise healthy newborns with hyperbilirubinemia if daily checkups and 24/7 telephone support can be provided. The parents should be informed to contact the hospital immediately if they fail to perform the treatment at home.

Place, publisher, year, edition, pages
Springer, 2021
Keywords
Neonatal jaundice, Home phototherapy, Total serum bilirubin
National Category
Pediatrics Nursing
Research subject
Pediatrics; Caring Sciences w. Medical Focus
Identifiers
urn:nbn:se:oru:diva-88723 (URN)10.1007/s00431-021-03932-4 (DOI)000608929900001 ()33469713 (PubMedID)2-s2.0-85100215281 (Scopus ID)
Note

Funding Agency:

Örebro University - Uppsala and Örebro regional county council  

Available from: 2021-01-19 Created: 2021-01-19 Last updated: 2021-05-26Bibliographically approved
Organisations
Identifiers
ORCID iD: ORCID iD iconorcid.org/0000-0003-3762-7627

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