Behavioural outcomes of children born with intrauterine growth restriction: protocol for a systematic review and meta-analysis

INTRODUCTION Intrauterine growth restriction (IUGR) is a pregnancy condition, which is associated with poor perinatal outcomes and long-term neurodevelopmental impairment. Several studies also investigated the impact of IUGR on child behaviour (eg, internalising and externalising behaviour, social competencies). However, so far, no systematic review or meta-analysis has been conducted that summarises these effects while considering relevant third variables such as type of IUGR diagnosis and control group, or concurrent cognitive abilities. The objective of this study is to summarise the current evidence regarding the relationship between IUGR and behavioural outcomes from early childhood to young adulthood. Additionally, to explore how third variables such as type of control group, or cognitive abilities, relate to this association. METHODS Search strategy: The following electronic databases will be searched-Web of Science, Medline Ovid, PsycInfo, Cochrane Library, Scopus and Embase. INCLUSION CRITERIA observational (eg, cohort studies and case-control studies) and intervention studies (if standard care is used and norm values are reported for the control group) will be included if they quantitatively compare children with and without IUGR from the age of 2 to 18 years. The main outcomes are internalising and externalising behaviour, and social competencies. ETHICS AND DISSEMINATION No ethics approval was necessary for this protocol. Dissemination of findings will be done by publishing the results in peer-reviewed journals. The results of this systematic review will provide guidance for practice and counselling for clinicians and therapists facing patients affected by IUGR and their families. PROSPERO REGISTRATION NUMBER CRD42022347467

Infant regulation during the pandemic: Associations with maternal response to the COVID-19 pandemic, well-being, and socio-emotional investment

In the transition to parenthood, the COVID-19 pandemic poses an additional strain on parental well-being. Confirmed infections or having to quarantine, as well as public health measures negatively affect parents and infants. Contrary to previous studies mainly focusing on the well-being of school-aged children and their parents during lockdown periods, the present study investigated how mothers of infants respond to the COVID-19 pandemic and whether this is related to maternal well-being, maternal socio-emotional investment, and infant regulation. Between April and June 2021, 206 mothers of infants (Mage = 7.14 months, SDage = 3.75 months) reported on COVID-19 infections, their response to the COVID-19 pandemic, their well-being, socio-emotional investment, and their infant's regulation. Exploratory factor analyses yielded five dimensions of maternal response to the COVID-19 pandemic: social distancing, worrying about the child, birth anxiety, distancing from the child, and information on COVID-19-related parenting behavior and support. These dimensions were related to mother-reported infant regulatory problems. Path analyses revealed paths via reduced maternal well-being and maternal socio-emotional investment. Maternal perceptions of infant regulatory problems are related to how the mothers respond to the COVID-19 pandemic. Better information about COVID-19-related parenting behavior and support might buffer against these effects

Survey and 10-Day Diary Data on Infant Nutrition, Development, and Home Learning Environment during the COVID-19 Pandemic from the LEARN-COVID Pilot Study

The LEARN-COVID pilot study collected data on infants and their parents during the COVID-19 pandemic. Assessments took place between April and July 2021. Parents (N = 357) from Switzerland (predominantly), Germany, and Austria answered a baseline questionnaire on their behaviour related to the pandemic, social support, infant nutrition, and infant regulation. Subsequently, parents (n = 222) answered a 10-day evening diary on infant nutrition, infant regulation, parental mood, and parental soothing behaviour. Data and documentation are stored on Zenodo, https://doi.org/10.5281/zenodo.6946048. These data may be valuable to researchers interested in infant development and parenting during the pandemic as well as to researchers interested in daily variability in infant behaviour, parenting, and nutrition

Creative Music Therapy and Neurodevelopmental Outcomes in Pre-term Infants at 2 Years: A Randomized Controlled Pilot Trial

Impaired neurodevelopment is increasingly recognized as a major health issue in children born prematurely. Creative music therapy (CMT) intends to prevent and or reduce neurobehavioral deficits in pre-term infants using musical stimulation and socio-emotional co-regulation. We conducted a randomized, clinical pilot CMT trial to test feasibility and to examine long-term neurodevelopmental outcomes in pre-term infants (NCT02434224: https://clinicaltrials.gov/ct2/show/NCT02434224). Eighty-two pre-term infants were randomized either to CMT or standard care. A specially trained music therapist provided family-integrating CMT via infant-directed singing during hospitalization. Fifty-six infants underwent follow-up at 2 years of corrected age. No significant beneficial nor adverse effects of CMT were identified in routine clinical neurodevelopmental measures (Bayley-III Scales of Infant and Toddler Development and the standardized neurological examination). Longer term follow-up (5 years) and larger future studies are recommended to elucidate possible long-term effects of music in relation to more sensitive outcomes including executive function, detailed language processing and social-emotional development

Survey and 10-Day Diary Data on Infant Nutrition, Development, and Home Learning Environment during the COVID-19 Pandemic from the LEARN-COVID Pilot Study

The LEARN-COVID pilot study collected data on infants and their parents during the COVID-19 pandemic. Assessments took place between April and July 2021. Parents (N = 357) from Switzerland (predominantly), Germany, and Austria answered a baseline questionnaire on their behaviour related to the pandemic, social support, infant nutrition, and infant regulation. Subsequently, parents (n = 222) answered a 10-day evening diary on infant nutrition, infant regulation, parental mood, and parental soothing behaviour. Data and documentation are stored on Zenodo, https://doi. org/10.5281/zenodo.6946048. These data may be valuable to researchers interested in infant development and parenting during the pandemic as well as to researchers interested in daily variability in infant behaviour, parenting, and nutrition

Creative music therapy for long-term neurodevelopment in extremely preterm infants: Results of a feasibility trial

AIM: We tested the feasibility of a future randomised clinical trial (RCT) in which Creative Music Therapy (CMT), a family-integrating individualised approach in neonatal care, could improve neurodevelopment in extremely preterm infants (EPTs). METHODS: In this feasibility trial, 12 EPTs received CMT, while the remaining 19 received standard neonatal care. Socio-demographic data and perinatal complications were compared between groups as risk factors. Bayley Scales of Infant and Toddler Development at 2-year follow-up (FU2) and KABC-II-Kaufman Assessment Battery for Children at 5-year follow-up (FU5) were analysed using the Mann-Whitney U-tests. RESULTS: Twenty-seven (87.1%) and 18 (58.1%) EPTs attended the FU2 and FU5 examination, respectively. The rate of neurodevelopmental risk factors at birth of the two groups was quite similar. While there was no difference in the FU2 outcomes between groups, there were higher values in the CMT group's Fluid-Crystallised Index of the KABC-II. CONCLUSION: Our results indicate neither a beneficial nor a detrimental effect of CMT on neurodevelopment at 2 years but a trend of improved cognitive outcomes at 5 years more similar to cognitive scores of term-born infants than of standard treatment EPTs. The findings favour an RCT but must be interpreted cautiously due to the reduced sample size and non-randomised design

Effect of Early High-Dose Recombinant Human Erythropoietin on Behavior and Quality of Life in Children Aged 5 Years Born Very Preterm: Secondary Analysis of a Randomized Clinical Trial

IMPORTANCE In light of the promising neuroprotective properties of recombinant human erythropoietin (RHEpo), the Swiss EPO Neuroprotection Trial was started to investigate its effect on neurodevelopment in very preterm infants. The results of the primary and secondary outcome analysis did not show any effect of RHEpo on cognitive performance, neuromotor outcomes, or somatic growth of the study participants at ages 2 or 5 years. OBJECTIVE To investigate whether early high-dose RHEpo improves behavioral outcomes and health-related quality of life (HRQoL) at age 5 years. DESIGN, SETTING, AND PARTICIPANTS This was a prespecified secondary analysis of the double-blind, placebo-controlled, multicenter Swiss EPO Neuroprotection randomized clinical trial, which was conducted at 5 level-III perinatal centers in Switzerland. Infants born between 26 weeks 0 days' and 31 weeks 6 days' gestation were recruited between 2005 and 2012 and followed-up until age 5 years (last follow-up in 2018). Data were analyzed from January 6 to December 31, 2021. INTERVENTIONS Infants were assigned to receive either RHEpo (3000 IU/kg) or placebo (saline, 0.9%) intravenously 3 times within the first 42 hours after birth. MAIN OUTCOMES AND MEASURES The prespecified parent-reported measures of behavioral outcomes and health-related quality of life (HRQoL) of their children at the age of 5 years were assessed by two standardized questionnaires: the Strengths and Difficulties Questionnaire (behavioral outcomes) and the KIDSCREEN-27 (HRQoL). RESULTS Among 448 randomized infants, 228 infants were assigned to the RHEpo group and 220 infants were assigned to the placebo group. Questionnaire data were available for 317 children (71%) at a mean (SD) age of 5.8 (0.4) years (mean [SD] gestational age at birth, 29.3 [1.6] weeks; mean [SD] birth weight 1220 [340] grams; 128 [40%] female infants). At the age 5 years follow-up, the mean (SD) total difficulties score in the RHEpo group (8.41 [5.60] points) was similar to that of the placebo group (7.76 [4.81]) (P = .37). There were no statistically significant differences between the groups in any other outcome measures. CONCLUSIONS AND RELEVANCE This secondary analysis of a randomized clinical trial showed no evidence for an effect of early high-dose RHEpo administration on behavioral outcomes or HRQoL in children born very preterm at early school age. TRIAL REGISTRATION - ClinicalTrials.gov Identifier: NCT00413946

Respiratory morbidity in preschool and school-age children born very preterm and its association with parents' health-related quality of life and family functioning

The purpose [CMC1] of this study is to describe [CMC2] the prevalence and severity of respiratory symptoms in children born very preterm and to assess their association with parents’ health-related quality of life (HRQoL) and family functioning. We conducted a cross-sectional study and recruited children born less than 32 weeks’ gestation between January 2006 and December 2019, in the greater Zurich area, Switzerland. Between May and December 2021, parents were invited to complete an online survey for their preterm child and for a control term born (≥ 37 weeks’ gestation) sibling aged 1 to 18 years. We used a validated questionnaire to assess respiratory symptoms and the Pediatrics Quality of Life Family Impact Module (PedsQL FIM) to assess parents’ HRQoL and family functioning. The survey was completed for 616 very preterm children (99 with bronchopulmonary dysplasia (BPD)) and 180 controls. Girls made up 45% (46% in controls) of the sample, and 63% (60% in controls) of participants were aged 6 to 18 years (school-age). Very preterm children reported a higher risk of respiratory symptoms than controls, especially preschoolers and those with moderate-to-severe BPD. Parents of children with “mild” and “moderate-severe” respiratory symptoms had on average −3.9 (95%CI: −6.6 to −1.1) and −8.2 (−11.2 to −5.2) lower PedsQL FIM total score, respectively, than parents of children with no symptoms. The same pattern was observed after stratifying by age categories. [CMC1]LE: Please check if the edit to the sentence “The purpose of this study is to...” retained its intended meaning. Otherwise, please amend. [CMC2]LE: As per journal style, abstract should be unstructured and should end with a conclusion as a new paragraph. Thus, the other headings were removed. Please check if appropriate.   Conclusions: Our study suggests that respiratory morbidity in very preterm children has a negative impact on parents’ HRQoL and family functioning, even beyond the first years of life. What is Known:• The burden of respiratory morbidity associated with very premature birth is high and last far beyond the neonatal period.• Respiratory morbidity contributes to lower health-related quality of life (HRQoL) in parents of very preterm children in early infancy. What is New:• Respiratory morbidity in very preterm children has a negative impact on parents’ HRQoL and family functioning beyond the first years of life.• Parents of very preterm children with moderate and severe respiratory symptoms are the ones who report lower scores, both for preschool and school-age children