Health-related quality of life in two birth cohorts of extremely preterm born adults.

AIM: Investigate potential long-term cohort influences on health-related quality of life (HRQoL) in adults born extremely preterm (EP) during the 1980-90s, in view of advancements in neonatal care within that timeframe. METHODS: Two cohorts of EP-born adults (82-85 cohort and 91-92 cohort) enrolling matched term controls, were compared. Participants were assessed at 18 years and again in their mid-twenties using the Child Health Questionnaire Children Form-87 (CHQ-CF87) and the Short Form Health Survey (SF-36). RESULTS: At 18 years, 77 (90%) EP-born and 75 (93%) term controls had data, followed by 67 (78%) EP-born and 66 (82%) term controls in their mid-twenties. At 18 years, there were no differences across the birth decades, and EP-born and term-born reported relatively similar HRQoL scores. In the mid-twenties, birth decade did also not significantly impact HRQoL scores, although the EP-born 82-85 cohort scored numerically poorer than the 91-92 cohort in three domains. Term controls scored similarly across birth decade in all domains. Regarding influence from neonatal factors, postnatal corticosteroids had a negative impact in some domains. CONCLUSION: No significant differences in HRQoL were observed between EP-born adults from the 82-85 cohort versus the 91-92 cohort, although the EP-born 82-85 cohort tended to score poorer in their mid-twenties.

ALPS-Neo pain and stress assessment scale for neonates-A measure for procedural pain.

AIM: The aim of this study was to investigate psychometric properties, reliability and validity, of Astrid Lindgren and Lund Children's Hospitals Pain and Stress Assessment Scale for Preterm and Sick Newborn Infants (ALPS-Neo), as a measure for procedural pain. METHODS: This observational, prospective study with a repeated measures design, explored inter-rater reliability by two raters assessing 21 neonates during non-pain and pain events. Construct validity was explored, that is, ability to discriminate between non-pain and pain, and criterion validity by correlating ALPS-Neo with Premature Infant Pain Profile-Revised (PIPP-R) and Skin Conductance Algesimeter (SCA) in 54 neonates without ventilator support and sedation undergoing routine heel-stick procedure in a tertiary neonatal intensive care unit. RESULTS: Mean gestational and assessment age of 54 infants was 33.8 weeks and 12.7 days respectively. Inter-rater reliability from baseline, skin wiping, heel-stick events for 21 infants demonstrated intraclass correlations with 95% confidence intervals (CI) of 0.49 (-0.27 to 0.79), 0.86 (0.65-0.94) and 0.73 (0.34-0.89) respectively. ALPS-Neo discriminated significantly between baseline, non-pain and heel-stick (mean differences from pain event -2.3 and -1.0 respectively) and correlated during heel-stick with PIPP-R (r = 0.56, 95% CI: 0.34-0.72), not with SCA. CONCLUSION: ALPS-Neo may be used as a measure for procedural pain.

Development of health-related quality of life and subjective health complaints in adults born extremely preterm: a longitudinal cohort study.

PURPOSE: To study development trajectories to 34 years of age of health-related quality of life (HRQoL) and subjective health complaints in extremely preterm (EP) born subjects with and without disability, and to compare with term-born controls. METHODS: A Norwegian longitudinal population-based cohort of subjects born in 1982-85 at gestational age ≤ 28 weeks or with birth weight ≤ 1000 g and matched term-born controls completed the Norwegian version of the Short Form Health Survey-36 at ages 24 and 34 and the Health Behaviour in School-aged Children-Symptom Checklist at ages 17, 24 and 34 years. Data were analysed by unadjusted and adjusted mixed effects analyses with time by subject group as interaction term. RESULTS: A total of 35/49 (73%) surviving EP-born and 36/46 (78%) term-born controls participated at this third follow-up. EP-born subjects with severe disability reported clinical significant lower mean score in all domains compared to the term-born controls. Healthy EP-born subjects reported significantly lower mean scores for vitality, role emotional and mental health, and significantly higher mean score for total and psychological health complaints compared to term-born controls. There were no significant interactions with age regarding HRQoL and somatic health complaints, while there were significant differences in psychological health complaints; the EP-born scored higher at age 24 and lower at age 34. CONCLUSIONS: EP-born adults at age 34 reported inferior HRQoL versus term-born peers, especially in the mental health domains, indicating that the negative differences observed at 24 years remained unchanged.

Pain assessment practices in Swedish and Norwegian neonatal care units.

BACKGROUND: The use of measurement scales to assess pain in neonates is considered a prerequisite for effective management of pain, but these scales are still underutilised in clinical practice. AIM: The aim of this study was to describe and compare pain assessment practices including the use of pain measurement scales in Norwegian and Swedish neonatal care units. METHODS: A unit survey investigating practices regarding pain assessment and the use of pain measurement scales was sent to all neonatal units in Sweden and Norway (n = 55). All Norwegian and 92% of Swedish units responded. RESULTS: A majority of the participating units (86.5%) assessed pain. Swedish units assessed and documented pain and used pain measurement scales more frequently than Norwegian units. The most frequently used scales were different versions of Astrid Lindgren's Pain Scale (ALPS) in Sweden and Echelle Douleur Inconfort Noveau-Ne (EDIN), ALPS and Premature Infant Pain Profile (PIPP) in Norway. Norwegian head nurses had more confidence in their pain assessment method and found the use of pain measurement scales more important than their Swedish colleagues. CONCLUSION: The persisting difference between Swedish and Norwegian units in pain assessment and the use of pain measurement scales are not easily explained. However, the reported increased availability and reported use of pain measurement scales in neonatal care units in both countries may be seen as a contribution towards better awareness and recognition of pain, better pain management and potentially less suffering for vulnerable neonates.

Music Therapy in Infancy and Neurodevelopmental Outcomes in Preterm Children: A Secondary Analysis of the LongSTEP Randomized Clinical Trial.

Importance: Preterm children are at risk for neurodevelopment impairments. Objective: To evaluate the effect of a music therapy (MT) intervention (parent-led, infant-directed singing) for premature children during the neonatal intensive care unit (NICU) stay and/or after hospital discharge on language development at 24 months' corrected age (CA). Design, Setting, and Participants: This predefined secondary analysis followed participants in the LongSTEP (Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers) randomized clinical trial, which was conducted from August 2018 to April 2022 in 8 NICUs across 5 countries (Argentina, Colombia, Israel, Norway, and Poland) and included clinic follow-up visits and extended interventions after hospital discharge. Intervention: Participants were children born preterm (<35 weeks' gestation) and their parents. Participants were randomized at enrollment to MT with standard care (SC) or SC alone; they were randomized to MT or SC again at discharge. The MT was parent-led, infant-directed singing tailored to infant responses and supported by a music therapist and was provided 3 times weekly in the NICU and/or in 7 sessions across 6 months after discharge. The SC consisted of early intervention methods of medical, nursing, and social services, without MT. Main Outcome and Measures: Primary outcome was language development, as measured by the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) language composite score, with the remaining BSID-III composite and subscale scores as the secondary outcomes. Group differences in treatment effects were assessed using linear mixed-effects models using all available data. Results: Of 206 participants (103 female infants [50%]; mean [SD] GA, 30.5 [2.7] weeks), 51 were randomized to MT and 53 to SC at enrollment; at discharge, 52 were randomized to MT and 50 to SC. A total of 112 (54%) were retained at the 24 months' CA follow-up. Most participants (79 [70%] to 93 [83%]) had BSID-III scores in the normal range (≥85). Mean differences for the language composite score were -2.36 (95% CI, -12.60 to 7.88; P = .65) for the MT at NICU with postdischarge SC group, 2.65 (95% CI, -7.94 to 13.23; P = .62) for the SC at NICU and postdischarge MT group, and -3.77 (95% CI, -13.97 to 6.43; P = .47) for the MT group at both NICU and postdischarge. There were no significant effects for cognitive or motor development. Conclusions and Relevance: This secondary analysis did not confirm an effect of parent-led, infant-directed singing on neurodevelopment in preterm children at 24 months' CA; wide CIs suggest, however, that potential effects cannot be excluded. Future research should determine the MT approaches, implementation time, and duration that are effective in targeting children at risk for neurodevelopmental impairments and introducing broader measurements for changes in brain development. Trial Registration: ClinicalTrials.gov Identifier: NCT03564184.

Effect of Music Therapy on Parent-Infant Bonding Among Infants Born Preterm: A Randomized Clinical Trial.

Importance: Parent-infant bonding contributes to long-term infant health but may be disrupted by preterm birth. Objective: To determine if parent-led, infant-directed singing, supported by a music therapist and initiated in the neonatal intensive care unit (NICU), improves parent-infant bonding at 6 and 12 months. Design, Setting, and Participants: This randomized clinical trial was conducted in level III and IV NICUs in 5 countries between 2018 and 2022. Eligible participants were preterm infants (under 35 weeks' gestation) and their parents. Follow-up was conducted across 12 months (as part of the LongSTEP study) at home or in clinics. Final follow-up was conducted at 12 months' infant-corrected age. Data were analyzed from August 2022 to November 2022. Intervention: Participants randomized to music therapy (MT) plus standard care or standard care alone during NICU admission, or to MT plus standard care or standard care alone postdischarge, using computer-generated randomization (ratio 1:1, block sizes of 2 or 4 varying randomly), stratified by site (51 allocated to MT NICU, 53 to MT postdischarge, 52 to both, and 50 to neither). MT consisted of parent-led, infant-directed singing tailored to infant responses and supported by a music therapist 3 times per week throughout hospitalization or 7 sessions across 6 months' postdischarge. Main Outcome and Measure: Primary outcome was mother-infant bonding at 6 months' corrected age, measured by the Postpartum Bonding Questionnaire (PBQ), with follow-up at 12 months' corrected age, and analyzed intention-to-treat as group differences. Results: Of 206 enrolled infants with 206 mothers (mean [SD] age, 33 [6] years) and 194 fathers (mean [SD] age, 36 [6] years) randomized at discharge, 196 (95.1%) completed assessments at 6 months and were analyzed. Estimated group effects for PBQ at 6 months' corrected age were 0.55 (95% CI, -2.20 to 3.30; P = .70) for MT in the NICU, 1.02 (95% CI, -1.72 to 3.76; P = .47) for MT postdischarge, and -0.20 (95% CI, -4.03 to 3.63; P = .92) for the interaction (12 months: MT in NICU, 0.17; 95% CI, -2.71 to 3.05; P = .91; MT postdischarge, 1.78; 95% CI, -1.13 to 4.70; P = .24; interaction, -1.68; 95% CI, -5.77 to 2.41; P = .42). There were no clinically important between-group differences for secondary variables. Conclusions and Relevance: In this randomized clinical trial, parent-led, infant-directed singing did not have clinically important effects on mother-infant bonding, but was safe and well-accepted. Trial Registration: ClinicalTrials.gov Identifier: NCT03564184.

Long-term follow-up of self-reported mental health and health-related quality of life in adults born extremely preterm.

BACKGROUND: Survival of extremely preterm (EP) birth is increasing, but long-term consequences are still largely unknown as their high survival rates are recent achievements. AIMS: To examine self-reported mental health, and health related quality of life (HRQoL) in a cohort of adults born EP in the early 1990s and individually matched term-born controls, and to describe development through the transition from teenager to adults. METHODS: Thirty-five eligible subjects were born at gestational age ≤ 28 weeks or with birth weight ≤ 1000 g during 1991-1992 in this population-based cohort from Western Norway. We assessed mental health using Youth Self-Report (YSR) at 18 years of age, and Adult Self-Report (ASR) at 27 years, and HRQoL by RAND-36 at 27 years. Data were analysed by unadjusted and adjusted mixed effects models with time by group as interaction term. RESULTS: At 27 years, 24 (69 %) EP-born and 26 (74 %) term-born controls participated. Scores for internalising problems, and syndrome scale anxious/depressed and withdrawn were higher among EP-born compared to term-born controls. For HRQoL, scores were similar in EP-born and term-born groups, except the domain physical functioning where EP-born scored lower. Development over time from 18 to 27 years showed increasing (i.e. deteriorating) scores for internalising, anxious/depressed, somatic complaints, and attention problems in the EP born group. For the term-born, scores for anxious/depression increased over time. CONCLUSIONS: At 27 years of age, EP-born adults reported more internalising problems than term-born controls, while HRQoL was relatively similar except physical functioning. Mental health problems in the EP-born increased from adolescence to adulthood.

Short-term Music Therapy for Families With Preterm Infants: A Randomized Trial.

OBJECTIVES: To evaluate short-term effects of music therapy (MT) for premature infants and their caregivers on mother-infant bonding, parental anxiety, and maternal depression. METHODS: Parallel, pragmatic, randomized controlled-trial conducted in 7 level III NICUs and 1 level IV NICU in 5 countries enrolling premature infants (<35 weeks gestational age at birth) and their parents. MT included 3 sessions per week with parent-led, infant-directed singing supported by a music therapist. Primary outcome was mother-infant bonding as measured by the Postpartum Bonding Questionnaire (PBQ) at discharge from NICU. Secondary outcomes were parents' symptoms of anxiety measured by General Anxiety Disorder-7 (GAD-7) and maternal depression measured by Edinburgh Postpartum Depression Scale (EPDS). Group differences at the assessment timepoint of discharge from hospital were tested by linear mixed effect models (ANCOVA). RESULTS: From August 2018 to April 2020, 213 families were enrolled in the study, of whom 108 were randomly assigned to standard care and 105 to MT. Of the participants, 208 of 213 (98%) completed treatment and assessments. Participants in the MT group received a mean (SD) of 10 sessions (5.95), and 87 of 105 participants (83%) received the minimum of 6 sessions. The estimated group effect (95% confidence interval) for PBQ was -0.61 (-1.82 to 0.59). No significant differences between groups were found (P = .32). No significant effects for secondary outcomes or subgroups were found. CONCLUSIONS: Parent-led, infant-directed singing supported by a music therapist resulted in no significant differences between groups in mother-infant bonding, parental anxiety, or maternal depression at discharge.

Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers (LongSTEP): Feasibility Study With a Norwegian Cohort.

Premature infants and their parents experience significant stress during the perinatal period. Music therapy (MT) may support maternal-infant bonding during this critical period, but studies measuring impact across the infant's first year are lacking. This nonrandomized feasibility study used quantitative and qualitative methods within a critical realist perspective to evaluate the feasibility, acceptability, and suitability of the treatment arm of the Longitudinal Study of music Therapy's Effectiveness for Premature infants and their caregivers (LongSTEP) (NCT03564184) trial with a Norwegian cohort (N = 3). Families were offered MT emphasizing parent-led infant-directed singing during neonatal intensive care unit (NICU) hospitalization and across 3 months post-discharge. We used inductive thematic analysis of semi-structured interviews with parents at discharge from NICU and at 3 months and analyzed quantitative variables descriptively. Findings indicate that: (1) parents of premature infants are willing to participate in MT research where parental voice is a main means of musical interaction; (2) parents are generally willing to engage in MT in NICU and post-discharge phases, finding it particularly interesting to note infant responsiveness and interaction over time; (3) parents seek information about the aims and specific processes involved in MT; (4) the selected self-reports are reasonable to complete; and (5) the Postpartum Bonding Questionnaire appears to be a suitable measure of impaired maternal-infant bonding. Parents reported that they were able to transfer resources honed during MT to parent-infant interactions outside MT and recognized parental voice as a central means of building relation with their infants. Results inform the implementation of a subsequent multinational trial that will address an important gap in knowledge.

Mental health and health related quality of life in mitochondrial POLG disease.

We aimed to assess the impact of POLG disease on mental health and quality of life in 15 patients using the Symptom Checklist-90-R (SCL-90-R) and Short-Form 36 Health Survey (RAND-36). We found increased scores in all nine subscales of SCL-90-R, particularly phobic anxiety, depression and somatization. Further, patients reported considerably lower scores in all RAND-36 domains. This study revealed a global decline in mental health and poor quality of life in patients with POLG disease and highlights the need for increased awareness and systematic assessment in order to improve their quality of life and mental health.

Longitudinal Study of music Therapy's Effectiveness for Premature infants and their caregivers (LongSTEP): protocol for an international randomised trial.

INTRODUCTION: Preterm birth has major medical, psychological and socioeconomic consequences worldwide. Music therapy (MT) has positive effects on physiological measures of preterm infants and maternal anxiety, but rigorous studies including long-term follow-up are missing. Drawing on caregivers' inherent resources, this study emphasises 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) hospitalisation 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 AND ANALYSIS: Design: international multicentre, assessor-blind, 2×2 factorial, pragmatic randomised controlled trial; informed by a completed feasibility study. Participants: 250 preterm infants and their parents. Intervention: MT focusing on parental singing specifically tailored to infant responses, will be delivered during NICU and/or during a postdischarge 6-month period. Primary outcome: changes in mother-infant bonding at 6-month corrected age (CA), as measured by the Postpartum Bonding Questionnaire. Secondary outcomes: mother-infant bonding at discharge and at 12-month CA; child development over 24 months; and parental depression, anxiety and stress, and infant rehospitalisation, all over 12 months. ETHICS AND DISSEMINATION: The Regional Committees for Medical and Health Research Ethics approved the study (2018/994/REK Nord, 03 July 2018). Service users were involved in development of the study and will be involved in implementation and dissemination. Dissemination of findings will apply to local, national and international levels. TRIAL REGISTRATION NUMBER: NCT03564184.

Health-related quality of life and emotional and behavioral difficulties after extreme preterm birth: developmental trajectories.

Background. Knowledge of long-term health related outcomes in contemporary populations born extremely preterm (EP) is scarce. We aimed to explore developmental trajectories of health-related quality of life (HRQoL) and behavior from mid-childhood to early adulthood in extremely preterm and term-born individuals. Methods. Subjects born at gestational age ≤28 weeks or with birth weight ≤1,000 g within a region of Norway in 1991-92 and matched term-born control subjects were assessed at 10 and 18 years. HRQoL was measured with the Child Health Questionnaire (CHQ) and behavior with the Child Behavior Checklist (CBCL), using parent assessment at both ages and self-assessment at 18 years. Results. All eligible EP (n = 35) and control children participated at 10 years, and 31 (89%) and 29 (83%) at 18 years. At 10 years, the EP born boys were given significantly poorer scores by their parents than term-born controls on most CHQ and CBCL scales, but the differences were minor at 18 years; i.e., significant improvements had occurred in several CHQ (self-esteem, general health and parental impact-time) and CBCL (total problem, internalizing and anxious/depressed) scales. For the girls, the differences were smaller at 10 years and remained unchanged by 18 years. Emotional/behavioral difficulties at 10 years similarly predicted poorer improvement on CHQ-scales for both EP and term-born subjects at 18 years. Self-assessment of HRQoL and behavior at 18 years was similar in the EP and term-born groups on most scales. Conclusions. HRQoL and behavior improved towards adulthood for EP born boys, while the girls remained relatively similar, and early emotional and behavioral difficulties predicted poorer development in HRQoL through adolescence. These data indicate that gender and a longitudinal perspective should be considered when addressing health and wellbeing after extremely preterm birth.

Pain tolerance and pain perception in adolescents born extremely preterm.

UNLABELLED: Neonatal pain experiences have been associated with altered processing and perception of pain in later life, but findings tend to vary among studies. We have compared experimental pain tolerance and subjective health complaints in a population-based cohort of adolescents born extremely preterm to that of matched term controls. Subjects performed a standardized cold pressor task (hand in ice water) and completed validated questionnaires regarding current subjective health complaints, including pain issues. Thirty-one (89%) of 35 eligible preterm subjects (mean gestational age 26.8 weeks) and 28 (80%) term controls participated in this follow-up study at mean age 17.8 years. Ten (32%) subjects born preterm versus 17 (61%) born at term reached the ceiling time of 180 seconds immersion time in the ice water, a hazard ratio for early withdrawal of 2.05 (95% confidence interval, 1.72 to 2.44), with males explaining most of the difference. For subjects born preterm, the risk of early withdrawal decreased significantly with more days of mechanical ventilation, more pain events, and more doses of morphine during the newborn period. Subjective pain ratings during the cold pressor task as well as health-related complaints and pain issues reported in the questionnaires were similar in the preterm and term groups. PERSPECTIVE: Despite reduced tolerance to experimental pain, subjects born preterm scored their pain experiences similarly to those of term controls. Surprisingly, preterm subjects exposed to most painful and invasive neonatal experiences and also to most doses of morphine had a pain response at follow-up most closely resembling that of the control group.

Psychometric testing of a Norwegian version of the Premature Infant Pain Profile: an acute pain assessment tool. A clinical validation study.

As neonates are submitted to pain, assessing the pain is crucial in effective pain control. The Premature Infant Pain Profile, an acute measurement tool combining physiological, behavioural and contextual indicators, was translated into Norwegian and tested clinically. The purpose was to establish construct validity, interrater reliability and internal consistency. In addition, the effect of sucrose as pain analgesia was tested in neonates >or= 36 weeks of gestational age. In a known-groups comparisons design with repeated measures, 111 consecutive neonates, preterm and term, were all observed at baseline, non-pain and pain event. Neonates in the neonatal unit received sucrose at pain event. A significant interaction effect of gestational age and events was found in the sucrose neonates. A significant interaction effect was detected from sucrose and event type for neonates from 36 weeks. The internal consistency of the six-item score was acceptable. A correlation coefficient of 0.89-0.97 was obtained for interrater reliability. The Norwegian version of the Premature Infant Pain Profile seems to be a reliable and valid instrument for pain assessment in neonates.