Preterm BirthLongSTEPNCT03564184
Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers
A study testing MT during NICU and MT after NICU in people with Preterm Birth, run by NORCE Norwegian Research Centre AS at 10 sites in 5 countries.
Trial summary
Background: Preterm birth has major medical, psychological and socio-economic consequences worldwide. A recent systematic review suggests positive effects of music therapy (MT) on physiological measures of preterm infants and maternal anxiety, but methodologically rigorous studies including long-term follow-up of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm Birth
- What is being tested?
- MT during NICU and MT after NICU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 25 Aug 2018to 31 Aug 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- born below 35 weeks gestational age
- determined by medical staff to have achieved sufficient medical stability to start MT
- likely to be hospitalized longer than 2 weeks from time of recruitment
- willing to engage in at least 2 of 3 MT sessions per week during NICU and/or in 5 of 7 MT post-discharge sessions, if randomized to receive MT
- live with reasonable commuting distance from the treating NICU
- sufficient understanding of the respective national language(s) to answer questionnaires and participate in MT
Who cannot join
- documented mental illness or cognitive impairment that prevents them from being able to complete the study intervention or outcome assessments
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Argentina3 sites
Hospital Materno Infantil Ramón Sardá
Buenos Aires, Buenos Aires F.D., 1246
Sanatorio Mater Dei
Buenos Aires, Buenos Aires F.D., C1425DND
Hospital Fernandez
Buenos Aires
Norway3 sites
Haukeland University Hospital, Barne-og ungdomsklinikken
Bergen, Hordaland, 5006
Akershus University Hospital
Oslo, Lørenskog, 1478
Oslo University Hospital, Rikshospitalet
Oslo, 0424
Colombia2 sites
Clinica de la Mujer
Bogotá
Fundación Santa Fe de Bogotá
Bogotá
About this study
Official title: Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers: International Randomized Trial
Background: Preterm birth has major medical, psychological and socio-economic consequences worldwide. A recent systematic review suggests positive effects of music therapy (MT) on physiological measures of preterm infants and maternal anxiety, but methodologically rigorous studies including long-term follow-up of infant and parental outcomes are missing. Drawing upon caregivers' inherent resources, this study emphasizes caregiver involvement in MT to promote attuned, developmentally-appropriate musical interactions that may be of mutual benefit to infant and parent. This study will determine whether MT, as delivered by a qualified music therapist during neonatal intensive care unit (NICU) hospitalization and/or in home/municipal settings following discharge, is superior to standard care in improving bonding between primary caregivers and preterm infants, parent well-being and infant development.
Methods: Design: International multi-center, assessor-blind, 2x2 factorial, pragmatic randomized controlled trial. A feasibility study has been completed; ethical approval for the main trial is pending. Participants: 250 preterm infants and their parents. Intervention: MT focusing on singing specifically tailored to infant responses, will be delivered during NICU and/or during a post-discharge 6-month period. Primary outcome: Changes in mother-infant bonding until 6 months corrected age (CA), as measured by the Postpartum Bonding Questionnaire. Secondary outcomes: Mother-infant bonding at discharge and over 12 months CA; child development over 24 months; and parental depression, anxiety, and stress, and infant re-hospitalization, all over 12 months.
Discussion: This study fills a gap by measuring the long-term impact of MT for preterm infants/caregivers, and of MT beyond the hospital context. Outcomes related to highly involving parents in MT will directly inform the development of clinical practice in Scandinavia and other contexts with similar social welfare practices. By incorporating family-centered care, continuity of care, user involvement, and cultural relevance, this study can potentially contribute to improved quality of care for premature infants and their parents worldwide.
- Conditions
- Preterm Birth
- Being tested
- MT during NICU, MT after NICU, Standard care
- Keywords
- Parent-infant bonding, Music therapy
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT during NICUBehavioural
Music therapy (MT) by trained music therapist, 3 times/week for 30-40 minutes/session during NICU hospitalization. Involves primary caregiver and infant in musical communication matched to infant post-menstrual age, family/cultural preferences, and infant readiness for stimulation. Music therapist assesses infant´s needs and behavior state, supports caregiver in using basic touch (e.g., hand lightly and statically on infant´s chest or back to perceive breathing pattern) and caregiver´s hummed/sung voice matched to infant behavioral responses, to promote infant state regulation and bonding. Music includes input from music therapist as needed, and multimodal aspects such as gentle dynamic touch when infant demonstrates readiness. MT may occur while infant is held in a static manner by caregiver or is resting in his/her isolette or basinet. MT may occur during skin-to-skin care, if such care is part of standard care.
MT after NICUBehavioural
Music therapy offered by trained music therapist, 7 times for approximately 45 minutes/session across first 6 months following discharge from initial NICU hospitalization. Sessions include infant and caregiver, and siblings, if desired, and occur at home or in municipal settings. MT after NICU consists of a consult-to-parent model with each session including a brief verbal check-in regarding infant´s progress, musical interactions with music therapist modelling musical engagement, discussion of current challenges and strategies for using musical interactions to address needs in areas such as infant self-regulation, parent/infant interaction, and challenges with bonding. Caregivers will demonstrate techniques discussed during session, and form a brief plan for use of musical interaction in the interim before next session. Sessions will be adapted to infant developmental level and ongoing needs.
Standard careOther
Includes necessary medical care and standard supportive interventions offered as part of care during hospitalization, and standard follow-up procedures post-hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| MT during and after NICU | Experimental | Consists of music therapy during NICU hospitalization, and music therapy after discharge from initial NICU hospitalization, along with standard care. Receives: Behavioral: MT during NICU; Behavioral: MT after NICU; Other: Standard care |
| MT during NICU | Experimental | Consists of music therapy during NICU hospitalization, along with standard care. Receives: Behavioral: MT during NICU; Other: Standard care |
| MT after NICU | Experimental | Consists of music therapy after discharge from initial NICU hospitalization, along with standard care. Receives: Behavioral: MT after NICU; Other: Standard care |
| No MT | Experimental | Consists of standard care. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bonding between primary caregiver and infant
Total score of the Postpartum Bonding Questionnaire (PBQ), a parent-rated screening instrument for disorders of the early mother-infant relationship consisting of 25 statements on a six-point Likert scale (each 0-5; sum score ranging from 0 to 125; high = problematic).
Measured: 6 months
Secondary outcomes (8)
Bonding between primary caregiver and infant
Total score of the Postpartum Bonding Questionnaire (PBQ), a parent-rated screening instrument for disorders of the early mother-infant relationship consisting of 25 statements on a six-point Likert scale (each 0-5; sum score ranging from 0 to 125; high = problematic).
Measured: 12 months
Child development
Bayley Scales of Infant and Toddler Development, 3rd edition (Bayley-III), standardized with a population mean of 100 (SD 15), with higher scores indicating better development
Measured: 24 months
Infant development
Ages and Stages Questionnaire, 3rd edition (ASQ-3), an age-specific parent-reported screening questionnaire consisting of 30 items, total sum score ranging from 0 to 300, with higher scores indicating better development.
Measured: 12 months
Infant socio-emotional development
Ages and Stages Questionnaire Social-Emotional (ASQ:SE), a parent-completed questionnaire with 19 or 22 Likert-scaled items (each 0-5-10), plus additional items for whether an item is of concern to the parent (each 0-5), resulting in a score ranging from 0-285 or 0-300, at 6 and 12 months respectively. Lower scores indicate better socio-emotional development.
Measured: 12 months
Re-hospitalization
Re-hospitalization excluding outpatient visits, based on electronic health records. This will be calculated as the time from initial discharge until first re-hospitalization.
Measured: 12 months
Maternal depression
Edinburgh Postnatal Depression Scale (EPDS), a 10-item validated self-report instrument assessing mothers' postpartum depressive symptoms, excluding somatic symptoms of depression that are common in new mothers (such as loss of energy, feeling tired, changes in appetite and sexual drive). Sum scores can range from 0 to 30, with high scores indicating more depressive symptoms.
Measured: 12 months
Parental anxiety
Generalized Anxiety Disorder Assessment (GAD-7), a self-report 7-item questionnaire serving as a screening tool and severity measure for generalized anxiety disorder. Sum scores can range from 0 to 21, with higher scores indicating higher anxiety.
Measured: 12 months
Parental stress
Parental Stress Scale (PSS), a self-report 18-item questionnaire that assesses stress associated with parenting. Sum scores can range from 18 to 90, with higher scores indicating higher stress.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start25 Aug 2018
- Primary completion31 Dec 2020
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial, multinational, single-blind trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- NORCE Norwegian Research Centre AS
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, University Hospital, Akershus, Oslo University Hospital, Meir Medical Center, Clinica de La Mujer, University of Haifa, University of Gdansk, King's College London, Universidad de Ciencias Empresariales y Sociales, Szpital Miejski w Rudzie Śląskiej, SONO - Centro de Musicoterapia, Hospital Materno Infantil Ramón Sardá, Hospital Fernandez
- Responsible party
- Principal investigator, Christian Gold, NORCE Norwegian Research Centre AS
- Investigators
- Christian Gold, PhD, Study chair, NORCE Norwegian Research CentreClaire Ghetti, PhD, Principal investigator, Grieg Academy, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564184
- Sponsor's protocol ID
- RCN 273534
- Acronym
- LongSTEP
- Status last verified
- Nov 2022
- First submitted
- 10 Jun 2018
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To promote transparency and applicability of trial results and to facilitate re- analysis by other researchers while also protecting anonymity, de-identified individual patient data will be made available through the Norwegian Centre for Research Data (NSD).
Publications
Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3):e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25.
PubMed 27561729Ghetti C, Bieleninik L, Hysing M, Kvestad I, Assmus J, Romeo R, Ettenberger M, Arnon S, Vederhus BJ, Soderstrom Gaden T, Gold C. Longitudinal Study of music Therapy's Effectiveness for Premature infants and their caregivers (LongSTEP): protocol for an international randomised trial. BMJ Open. 2019 Sep 3;9(8):e025062. doi: 10.1136/bmjopen-2018-025062.
PubMed 31481362Bieleninik L, Kvestad I, Gold C, Stordal AS, Assmus J, Arnon S, Elefant C, Ettenberger M, Gaden TS, Haar-Shamir D, Havardstun T, Lichtensztejn M, Mangersnes J, Wiborg AN, Vederhus BJ, Ghetti CM. Music Therapy in Infancy and Neurodevelopmental Outcomes in Preterm Children: A Secondary Analysis of the LongSTEP Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2410721. doi: 10.1001/jamanetworkopen.2024.10721.
PubMed 38753331Bauer-Rusek S, Shalit S, Yakobson D, Levkovitz O, Ghetti C, Gold C, Stordal AS, Arnon S. Music therapy and weight gain in preterm infants: Secondary analysis of the randomized controlled LongSTEP trial. J Pediatr Gastroenterol Nutr. 2024 Jan;78(1):113-121. doi: 10.1002/jpn3.12061. Epub 2023 Dec 10.
PubMed 38291685Ettenberger M, Bieleninik L, Stordal AS, Ghetti C. The effect of paternal anxiety on mother-infant bonding in neonatal intensive care. BMC Pregnancy Childbirth. 2024 Jan 11;24(1):55. doi: 10.1186/s12884-023-06179-z.
PubMed 38212696Ghetti CM, Gaden TS, Bieleninik L, Kvestad I, Assmus J, Stordal AS, Aristizabal Sanchez LF, Arnon S, Dulsrud J, Elefant C, Epstein S, Ettenberger M, Glosli H, Konieczna-Nowak L, Lichtensztejn M, Lindvall MW, Mangersnes J, Murcia Fernandez LD, Roed CJ, Saa G, Van Roy B, Vederhus BJ, Gold C. Effect of Music Therapy on Parent-Infant Bonding Among Infants Born Preterm: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2315750. doi: 10.1001/jamanetworkopen.2023.15750.
PubMed 37234006Gaden TS, Gold C, Assmus J, Kvestad I, Stordal AS, Bieleninik L, Ghetti C. Treatment fidelity in a pragmatic clinical trial of music therapy for premature infants and their parents: the LongSTEP study. Trials. 2023 Mar 3;24(1):160. doi: 10.1186/s13063-022-06971-w.
PubMed 36869392Gaden TS, Ghetti C, Kvestad I, Bieleninik L, Stordal AS, Assmus J, Arnon S, Elefant C, Epstein S, Ettenberger M, Lichtensztejn M, Lindvall MW, Mangersnes J, Roed CJ, Vederhus BJ, Gold C. Short-term Music Therapy for Families With Preterm Infants: A Randomized Trial. Pediatrics. 2022 Feb 1;149(2):e2021052797. doi: 10.1542/peds.2021-052797.
PubMed 34988583
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers: International Randomized Trial
- ClinicalTrials.gov ID
- NCT03564184
- Acronym / sponsor ID
- LongSTEP / RCN 273534
- Conditions
- Preterm Birth
- Keywords
- Parent-infant bonding, Music therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- NORCE Norwegian Research Centre ASUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, University Hospital, Akershus, Oslo University Hospital, Meir Medical Center, Clinica de La Mujer, University of Haifa, University of Gdansk, King's College London, Universidad de Ciencias Empresariales y Sociales, Szpital Miejski w Rudzie Śląskiej, SONO - Centro de Musicoterapia, Hospital Materno Infantil Ramón Sardá, Hospital Fernandez
- Study start
- 25 Aug 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 20 Jun 2018 (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.
Background: Preterm birth has major medical, psychological and socio-economic consequences worldwide. A recent systematic review suggests positive effects of music therapy (MT) on physiological measures of preterm infants and maternal anxiety, but methodologically rigorous studies including long-term follow-up of infant and parental outcomes are missing. Drawing upon caregivers' inherent resources, this study emphasizes caregiver involvement in MT to promote attuned, developmentally-appropriate musical interactions that may be of mutual benefit to infant and parent. This study will determine whether MT, as delivered by a qualified music therapist during neonatal intensive care unit (NICU) hospitalization and/or in home/municipal settings following discharge, is superior to standard care in improving bonding between primary caregivers and preterm infants, parent well-being and infant development.
Methods: Design: International multi-center, assessor-blind, 2x2 factorial, pragmatic randomized controlled trial. A feasibility study has been completed; ethical approval for the main trial is pending. Participants: 250 preterm infants and their parents. Intervention: MT focusing on singing specifically tailored to infant responses, will be delivered during NICU and/or during a post-discharge 6-month period. Primary outcome: Changes in mother-infant bonding until 6 months corrected age (CA), as measured by the Postpartum Bonding Questionnaire. Secondary outcomes: Mother-infant bonding at discharge and over 12 months CA; child development over 24 months; and parental depression, anxiety, and stress, and infant re-hospitalization, all over 12 months.
Discussion: This study fills a gap by measuring the long-term impact of MT for preterm infants/caregivers, and of MT beyond the hospital context. Outcomes related to highly involving parents in MT will directly inform the development of clinical practice in Scandinavia and other contexts with similar social welfare practices. By incorporating family-centered care, continuity of care, user involvement, and cultural relevance, this study can potentially contribute to improved quality of care for premature infants and their parents worldwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2 factorial, multinational, single-blind trial
| Arm | Type | Receives |
|---|---|---|
| MT during and after NICU | Experimental | Behavioral: MT during NICU, Behavioral: MT after NICU, Other: Standard careConsists of music therapy during NICU hospitalization, and music therapy after discharge from initial NICU hospitalization, along with standard care. |
| MT during NICU | Experimental | Behavioral: MT during NICU, Other: Standard careConsists of music therapy during NICU hospitalization, along with standard care. |
| MT after NICU | Experimental | Behavioral: MT after NICU, Other: Standard careConsists of music therapy after discharge from initial NICU hospitalization, along with standard care. |
| No MT | Experimental | Other: Standard careConsists of standard care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- born below 35 weeks gestational age
- determined by medical staff to have achieved sufficient medical stability to start MT
- likely to be hospitalized longer than 2 weeks from time of recruitment
- willing to engage in at least 2 of 3 MT sessions per week during NICU and/or in 5 of 7 MT post-discharge sessions, if randomized to receive MT
- live with reasonable commuting distance from the treating NICU
Key exclusion criteria (1 listed)
- documented mental illness or cognitive impairment that prevents them from being able to complete the study intervention or outcome assessments
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 |
|---|---|---|
| MT during NICUMusic therapy (MT) by trained music therapist, 3 times/week for 30-40 minutes/session during NICU hospitalization. Involves primary caregiver and infant in musical communication matched to infant post-menstrual age, family/cultural preferences, and infant readiness for stimulation. Music therapist assesses infant´s needs and behavior state, supports caregiver in using basic touch (e.g., hand lightly and statically on infant´s chest or back to perceive breathing pattern) and caregiver´s hummed/sung voice matched to infant behavioral responses, to promote infant state regulation and bonding. Music includes input from music therapist as needed, and multimodal aspects such as gentle dynamic touch when infant demonstrates readiness. MT may occur while infant is held in a static manner by caregiver or is resting in his/her isolette or basinet. MT may occur during skin-to-skin care, if such care is part of standard care. | Behavioural | MT during NICU, MT during and after NICU |
| MT after NICUMusic therapy offered by trained music therapist, 7 times for approximately 45 minutes/session across first 6 months following discharge from initial NICU hospitalization. Sessions include infant and caregiver, and siblings, if desired, and occur at home or in municipal settings. MT after NICU consists of a consult-to-parent model with each session including a brief verbal check-in regarding infant´s progress, musical interactions with music therapist modelling musical engagement, discussion of current challenges and strategies for using musical interactions to address needs in areas such as infant self-regulation, parent/infant interaction, and challenges with bonding. Caregivers will demonstrate techniques discussed during session, and form a brief plan for use of musical interaction in the interim before next session. Sessions will be adapted to infant developmental level and ongoing needs. | Behavioural | MT after NICU, MT during and after NICU |
| Standard careIncludes necessary medical care and standard supportive interventions offered as part of care during hospitalization, and standard follow-up procedures post-hospitalization. | Other | MT after NICU, MT during NICU, MT during and after NICU, No MT |
Primary outcome
Bonding between primary caregiver and infant
Time frame: 6 months
Total score of the Postpartum Bonding Questionnaire (PBQ), a parent-rated screening instrument for disorders of the early mother-infant relationship consisting of 25 statements on a six-point Likert scale (each 0-5; sum score ranging from 0 to 125; high = problematic).
8 secondary outcomes
Bonding between primary caregiver and infant
Time frame: 12 months
Child development
Time frame: 24 months
Infant development
Time frame: 12 months
Infant socio-emotional development
Time frame: 12 months
Re-hospitalization
Time frame: 12 months
Maternal depression
Time frame: 12 months
Parental anxiety
Time frame: 12 months
Parental stress
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Background: PubMed 27561729Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3):e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25.
- Background: PubMed 31481362Ghetti C, Bieleninik L, Hysing M, Kvestad I, Assmus J, Romeo R, Ettenberger M, Arnon S, Vederhus BJ, Soderstrom Gaden T, Gold C. Longitudinal Study of music Therapy's Effectiveness for Premature infants and their caregivers (LongSTEP): protocol for an international randomised trial. BMJ Open. 2019 Sep 3;9(8):e025062. doi: 10.1136/bmjopen-2018-025062.
- Derived from this study: PubMed 38753331Bieleninik L, Kvestad I, Gold C, Stordal AS, Assmus J, Arnon S, Elefant C, Ettenberger M, Gaden TS, Haar-Shamir D, Havardstun T, Lichtensztejn M, Mangersnes J, Wiborg AN, Vederhus BJ, Ghetti CM. Music Therapy in Infancy and Neurodevelopmental Outcomes in Preterm Children: A Secondary Analysis of the LongSTEP Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2410721. doi: 10.1001/jamanetworkopen.2024.10721.
- Derived from this study: PubMed 38291685Bauer-Rusek S, Shalit S, Yakobson D, Levkovitz O, Ghetti C, Gold C, Stordal AS, Arnon S. Music therapy and weight gain in preterm infants: Secondary analysis of the randomized controlled LongSTEP trial. J Pediatr Gastroenterol Nutr. 2024 Jan;78(1):113-121. doi: 10.1002/jpn3.12061. Epub 2023 Dec 10.
- Derived from this study: PubMed 38212696Ettenberger M, Bieleninik L, Stordal AS, Ghetti C. The effect of paternal anxiety on mother-infant bonding in neonatal intensive care. BMC Pregnancy Childbirth. 2024 Jan 11;24(1):55. doi: 10.1186/s12884-023-06179-z.
- Derived from this study: PubMed 37234006Ghetti CM, Gaden TS, Bieleninik L, Kvestad I, Assmus J, Stordal AS, Aristizabal Sanchez LF, Arnon S, Dulsrud J, Elefant C, Epstein S, Ettenberger M, Glosli H, Konieczna-Nowak L, Lichtensztejn M, Lindvall MW, Mangersnes J, Murcia Fernandez LD, Roed CJ, Saa G, Van Roy B, Vederhus BJ, Gold C. Effect of Music Therapy on Parent-Infant Bonding Among Infants Born Preterm: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2315750. doi: 10.1001/jamanetworkopen.2023.15750.
- Derived from this study: PubMed 36869392Gaden TS, Gold C, Assmus J, Kvestad I, Stordal AS, Bieleninik L, Ghetti C. Treatment fidelity in a pragmatic clinical trial of music therapy for premature infants and their parents: the LongSTEP study. Trials. 2023 Mar 3;24(1):160. doi: 10.1186/s13063-022-06971-w.
- Derived from this study: PubMed 34988583Gaden TS, Ghetti C, Kvestad I, Bieleninik L, Stordal AS, Assmus J, Arnon S, Elefant C, Epstein S, Ettenberger M, Lichtensztejn M, Lindvall MW, Mangersnes J, Roed CJ, Vederhus BJ, Gold C. Short-term Music Therapy for Families With Preterm Infants: A Randomized Trial. Pediatrics. 2022 Feb 1;149(2):e2021052797. doi: 10.1542/peds.2021-052797.
- Project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. To promote transparency and applicability of trial results and to facilitate re- analysis by other researchers while also protecting anonymity, de-identified individual patient data will be made available through the Norwegian Centre for Research Data (NSD).
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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.
Christian Gold, PhD study chair
NORCE Norwegian Research Centre
Claire Ghetti, PhD principal investigator
Grieg Academy, University of Bergen
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MT during NICU and MT after NICU in people with Preterm Birth, run by NORCE Norwegian Research Centre AS at 10 sites in 5 countries.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Argentina, Norway, Colombia, Israel, Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bonding between primary caregiver and infant (time frame: 6 months). 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 NCT03564184, which also lists 8 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 22 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.