Early intervention influences positively quality of life as reported by prematurely born children at age nine and their parents; a randomized clinical trial

License: Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0).Background: The Tromsø Intervention Study on Preterms evaluates an early, sensitizing intervention given to parents of prematurely born children (birth-weight < 2000 g). The current study investigated the potential influence of the intervention on children’s self-reported and parental proxy-reported quality of life (QoL) at children’s age of nine. Methods: Participants were randomized to either intervention (PI, n = 72) or preterm control (PC, n = 74) in the neonatal care unit, while healthy term-born infants were recruited to a term reference group (TR, n = 75). The intervention was a modified version of the Mother-Infant Transaction Program, and comprised eight one-hour sessions during the last week before discharge and four home visits at 1, 2, 4 and 12 weeks post-discharge. The two control groups received care in accordance with written guidelines drawn up at the hospital. Participants and parents reported QoL independently on the Kinder Lebensqualität Fragebogen (KINDL) questionnaire. Differences between groups were analyzed by SPSS; Linear Mixed Models and parent–child agreement were analyzed and compared by intra-class correlations within each group. Results: On average, children in all groups reported high levels of well-being. The PI children reported better physical well-being than the PC children (p = 0.002). In all other aspects of QoL both the PI and the PC children reported at similar levels as the term reference group. PI parents reported better emotional wellbeing (p = 0.05) and a higher level of contentment in school (p = 0.003) compared with PC parents. Parent–child agreement was significantly weaker in the PI group than in the PC group on dimensions such as emotional well-being and relationships with friends (p < 0.05). PI parents reported QoL similar to parents of terms on all aspects except the subscale self-esteem, while PC parents generally reported moderately lower QoL than TR parents. Conclusions: This early intervention appears to have generated long-lasting positive effects, improving perceived physical well-being among prematurely born children and parent’s perception of these children’s QoL in middle childhood

Two-year motor outcomes associated with the dose of NICU based physical therapy: The Noppi RCT

Background - Interventions involving both the parent and the preterm infant have demonstrated lasting effects on cognitive outcomes, but motor effects are less salient. It remains unclear when to commence early intervention and if dosages have impact on motor outcomes. Aims - To examine the effect on motor performance at 24-months corrected age following a parent-administered intervention performed with infants born preterm in the NICU. Intervention dosing and longitudinal motor performance were also analyzed. Study design - Single-blinded randomized multicenter clinical trial. Subjects - 153 infants born, gestational age ≤ 32 weeks at birth, were randomized into intervention or control group. Outcome measures - Infant Motor Performance Screening Test, Test of Infant Motor Performance, Peabody Developmental Motor Scales-2. Results - No significant difference was found between the intervention and the control group assessed with the PDMS-2 at 24-months CA. However, a significant positive association was found between dosing and the Gross Motor and Total Motor PDMS-2 scores. Analysis of longitudinal motor performance showed a decreasing motor performance between 6- and 24-months corrected age in both groups. Conclusions - There was no difference in motor performance between groups at 24-months corrected age. However, increased intervention dosage was positively associated with improved motor outcome

Study protocol: an early intervention program to improve motor outcome in preterm infants: a randomized controlled trial and a qualitative study of physiotherapy performance and parental experiences

Background Knowledge about early physiotherapy to preterm infants is sparse, given the risk of delayed motor development and cerebral palsy. Methods/Design A pragmatic randomized controlled study has been designed to assess the effect of a preventative physiotherapy program carried out in the neonatal intensive care unit. Moreover, a qualitative study is carried out to assess the physiotherapy performance and parents' experiences with the intervention. The aim of the physiotherapy program is to improve motor development i.e. postural control and selective movements in these infants. 150 infants will be included and randomized to either intervention or standard follow-up. The infants in the intervention group will be given specific stimulation to facilitate movements based on the individual infant's development, behavior and needs. The physiotherapist teaches the parents how to do the intervention and the parents receive a booklet with photos and descriptions of the intervention. Intervention is carried out twice a day for three weeks (week 34, 35, 36 postmenstrual age). Standardized tests are carried out at baseline, term age and at three, six, 12 and 24 months corrected age. In addition eight triads (infant, parent and physiotherapist) are observed and videotaped in four clinical encounters each to assess the process of physiotherapy performance. The parents are also interviewed on their experiences with the intervention and how it influences on the parent-child relationship. Eight parents from the follow up group are interviewed about their experience. The interviews are performed according to the same schedule as the standardized measurements. Primary outcome is at two years corrected age. Discussion The paper presents the protocol for a randomized controlled trial designed to study the effect of physiotherapy to preterm infants at neonatal intensive care units. It also studies physiotherapy performance and the parent's experiences with the intervention

Does a parent-administrated early motor intervention influence general movements and movement character at 3 months of age in infants born preterm?

Background: Studies of preterm and term-born infants have shown absent fidgety movements and an abnormal movement character to be related to brain lesions and unfavourable neurological outcomes. Aims: The present study examines what effect a parent-administered early intervention program applied to preterm infants in a randomised control trial (RCT) between 34 and 36 weeks gestational age has on their fidgety movements and overall movement character at three months of age. Study design: The study was part of the RCT in an early intervention programme including preterm infants born between 2010 and 2014 at three Norwegian university hospitals. Subjects: 130 preterm infants participated in the study, with 59 of them in the control group and 71 in the intervention group. Outcome measures: Fidgety movements and overall movement character at three months corrected age. Results: No difference was found between the intervention group and the control group in terms of fidgety movements or movement character. Approximately half of the infants in both groups showed an abnormal movement character. Conclusion: No evidence was found in this RCT to suggest that an intervention at 34 to 37 weeks gestational age has a significant effect on the fidgety movements or overall movement character of preterm infants. This is in line with the assumption that absent fidgety movements and an abnormal movement character are due to permanent brain injury and are therefore good predictors for later neurological impairments

Effect of Transverse Aortic Constriction on Cardiac Structure, Function and Gene Expression in Pregnant Rats

Background: There is an increased risk of heart failure and pulmonary edema in pregnancies complicated by hypertensive disorders. However, in a previous study we found that pregnancy protects against fibrosis and preserves angiogenesis in a rat model of angiotensin II induced cardiac hypertrophy. In this study we test the hypothesis that pregnancy protects against negative effects of increased afterload. Methods: Pregnant (gestational day 5.5–8.5) and non-pregnant Wistar rats were randomized to transverse aortic constriction (TAC) or sham surgery. After 14.260.14 days echocardiography was performed. Aortic blood pressure and left ventricular (LV) pressure-volume loops were obtained using a conductance catheter. LV collagen content and cardiomyocyte circumference were measured. Myocardial gene expression was assessed by real-time polymerase chain reaction. Results: Heart weight was increased by TAC (p,0.001) but not by pregnancy. Cardiac myocyte circumference was larger in pregnant compared to non-pregnant rats independent of TAC (p = 0.01), however TAC per se did not affect this parameter. Collagen content in LV myocardium was not affected by pregnancy or TAC. TAC increased stroke work more in pregnant rats (34.162.4 vs 17.562.4 mmHg/mL, p,0.001) than in non-pregnant (28.261.7 vs 20.961.5 mmHg/mL, p = 0.06). However, it did not lead to overt heart failure in any group. In pregnant rats, a-MHC gene expression was reduced by TAC. Increased in the expression of b-MHC gene was higher in pregnant (5-fold) compared to non-pregnant rats (2-fold) after TAC (p = 0.001). Nine out of the 19 genes related to cardiac remodeling were affected by pregnancy independent of TAC. Conclusions: This study did not support the hypothesis that pregnancy is cardioprotective against the negative effects of increased afterload. Some differences in cardiac structure, function and gene expression between pregnant and nonpregnant rats following TAC indicated that afterload increase is less tolerated in pregnancy

Effects of a parent-administered exercise program in the neonatal intensive care unit: Dose does matter-a randomized controlled trial

Background - Despite the risk of delayed motor development in infants born preterm, knowledge about interventions in the neonatal intensive care unitt (NICU) and the effects of dosing is sparse. Objective - The objectives of this study were to examine the effectiveness of a parent-administered exercise program in the NICU on motor outcome at 3 months corrected age (CA) and the effect of dosing on motor performance. Design - This was a randomized clinical trial. Setting The study was conducted at 3 university hospitals in Tromsø, Trondheim, and Oslo, Norway. Participants - A total of 153 infants with gestational age Intervention - A 3-week parent-administered intervention designed to facilitate movements in preterm infants was performed in the NICU. Parents were asked to administer the intervention 10 minutes twice a day. Measurements - Test of Infant Motor Performance (TIMP) was used to assess short-term outcome at 3 months CA. Results - No significant difference in the TIMP z-score was found between intervention and control groups at follow-up 3 months CA, but a significant positive relationship was found between total intervention dose and TIMP z-scores. The adjusted odds of having a clinical z-score Limitations - The number of infants born before 28 weeks was small. A spillover effect in favor of the control group was possible. We do not know if the infants received physical therapy after discharge from the hospital. Conclusions - There was no difference in motor performance between the intervention group and the control group at 3 months CA. However, an increased intervention dose was positively associated with improved motor outcome

Light microscopy of heart tissue.

<p>Histological section of heart tissue (200x) stained with toluidine blue to enhance the contour of the cardiomyocytes for measuring their circumference and immunohistochemistry using non-muscular β-actin to stain capillaries (brown). One cardiomyocyte cut in short axis and containing a nucleus (blue) is outlined and magnified (box) to show how cardiomyocyte circumference was measured (in arbitrary units).</p

Myocyte transverse circumference and collagen content in myocardial tissue.

<p>Myocyte transverse circumference (A) expressed in arbitrary units (a.u.) and collagen content in myocardial tissue (B) expressed as % tissue area stained by Sirius Red presented as mean±SEM. Comparisons between groups were made using one-way ANOVA and Holm-Sidak post hoc test. NP, non-pregnant, TAC, transverse aorta constriction. p<0.05 compared to non-pregnant sham (*).</p

Blood pressure, heart weight and heart weight/tibia length ratio.

<p>Mean±SEM for diastolic (A) and systolic (B) blood pressure in ascending aorta, heart weight (C) and heart weight/tibia length ratio (D). Comparisons between groups were made using one-way ANOVA and Holm-Sidak post hoc test. NP, non-pregnant, TAC, transverse aorta constriction. p<0.05 compared to non-pregnant sham (*), non-pregnant TAC (†), or pregnant sham rats (‡).</p