Dataset Information

Early Physiotherapy Intervention Program for Preterm Infants and Parents: A Randomized, Single-Blind Clinical Trial.

ABSTRACT:

Background

The early developmental interventions might be designed with a preventative approach to improving the development of at-risk preterm infants. The present study aimed to evaluate the effectiveness of an early physiotherapy intervention on preterm infants' motor and global development, and on parents' stress index.

Methods

48 infants were enrolled and randomized into two groups. Infants allocated to the intervention group received an early physiotherapy intervention, based on parental education sessions and tactile and kinesthetic stimulation during the NICU period, as well as a home-based activity program. The intervention commenced after 32 weeks post-menstrual age and ended at 2 months corrected age. Infants allocated to the control group received the usual care based on the NIDCAP-care.

Results

No differences were found between groups on the Alberta Infant Motor Scale at 2- or 8-months corrected age. Infants in the intervention group showed more optimal fine motor, problem-solving, personal-social, and communication development at 1 month corrected age.

Conclusions

The results showed no effect on the early physiotherapy intervention. Results might be related to the dose or intensity of the intervention, but also to the poor parental compliance.

Clinicaltrials

gov NCT03313427.

SUBMITTER: Ochandorena-Acha M

PROVIDER: S-EPMC9222162 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

Early Physiotherapy Intervention Program for Preterm Infants and Parents: A Randomized, Single-Blind Clinical Trial.

Ochandorena-Acha Mirari M Terradas-Monllor Marc M López Sala Laura L Cazorla Sánchez Maria Engracia ME Fornaguera Marti Montserrat M Muñoz Pérez Isabel I Agut-Quijano Thais T Iriondo Martín M Casas-Baroy Joan Carles JC

Children (Basel, Switzerland) 20220615 6

<h4>Background</h4>The early developmental interventions might be designed with a preventative approach to improving the development of at-risk preterm infants. The present study aimed to evaluate the effectiveness of an early physiotherapy intervention on preterm infants' motor and global development, and on parents' stress index.<h4>Methods</h4>48 infants were enrolled and randomized into two groups. Infants allocated to the intervention group received an early physiotherapy intervention, base ...[more]

PMID: 35740832

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Project description:BackgroundPreterm infants are high risk for delayed neurodevelopment. The main goal is to develop a program of early intervention for very preterm infants that allows families to apply it continuously at home, and quantify the results of early parental stimulation on improvement of cognition and motor skills.MethodsRandomized clinical Trial including inborn preterm infants with gestational age less than 32 weeks or birth weight less than 1500 g at 48 h after birth. Eligible for begin the intervention up to 7 days after birth. Study Protocol approved by the Brazilian national Committee of ethics in Research and by the institutional ethics committee. Intervention group (IG): skin-to skin care by mother (kangaroo care) plus tactile-kinesthetic stimulation by mothers from randomization until hospital discharge when they receive a program of early intervention with 10 parents' orientation and a total of 10 home visits independently of the standard evaluation and care that will be performed. Systematic early intervention program will be according to developmental milestones, anticipating in a month evolutionary step acquisition of motor and / or cognitive expected for corrected age. Active comparator with a Conventional Group (CG): standard care according to the routine care of the NICU and their needs in the follow up program. Neurodevelopment outcome with blinded evaluations in both groups between 12 and 18 months by Bayley Scales of Infant and Toddler Development third edition and Alberta Motor Infant scale will be performed. All evaluations will be conducted in the presence of parents or caregivers in a safe room for the child move around during the evaluation.DiscussionIf we can show that a continuous and global early intervention at home performed by low income families is better than the standard care for very preterm infants, this kind of program may be applied elsewhere in the world. We received grants by Bill and Melinda Gates Foundation, DECIT, Cnpq and Health Ministry. Grand Challenges Brazil: All Children Thriving.Trial registrationThe study was restrospectively registered in ClinicalTrials.gov . in July 15 2016 ( NCT02835612 ).

Project description:Knowledge about early physiotherapy to preterm infants is sparse, given the risk of delayed motor development and cerebral palsy.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.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.ClinicalTrials.gov NCT01089296.

Project description:BackgroundThe implementation of early intervention (EI) in medical settings is time-consuming and resource-intensive, which limits its extensive use. In 2018, the Chinese Eugenics Association developed a home-based, post-discharge EI program. This study aims at evaluating the impact of this EI program on neurodevelopment and physical growth of early preterm infants.MethodsThis study was a prospective, partially blinded, randomized controlled trial (RCT), followed by an open phase. A total of 73 infants born at 28+ 0 ~ 31+ 6 weeks' gestation who were admitted to the Children's Hospital of Chongqing Medical University between December 1, 2019, and June 31, 2020, were enrolled. Another 33 infants were retrospectively recruited as the reference group. Thirty-seven infants randomized in the first early intervention, then standard care (EI-SC) group performed a 30-day EI during RCT period, while 36 infants allocated to SC-EI group were given EI in the following open phase. The test of infant motor performance (TIMP), development quotient (DQ), and anthropometric measures (length, weight, head circumference) were measured at the baseline (T0), termination of the RCT (T1), and termination of the open phase (T2). Repeated measures analysis was performed for comparison among groups.ResultsFrom T0 to T1, both groups had significant improvements in all outcome measures (all p < 0.001). A 30-day EI program was more effective in improving TIMP than standard care (from 53.12 ± 8.79 to 83.50 ± 11.85 in EI-SC group vs from 50.52 ± 8.64 to 75.97 ± 13.44 in SC-EI group, F = 4.232, p = 0.044). EI-SC group also had greater improvements in length, weight, and head circumference than SC-EI group (all p < 0.05). From T0 to T2, there was no significant difference regarding the improvements in all outcomes between the groups (all p > 0.05). At the endpoint of T2, the EI-SC and SC-EI group had similar TIMP and anthropometric measures, but much higher than the reference group (all p < 0.05).ConclusionsThese findings demonstrated that a home-based, post-discharge EI program in this study was a practical approach to promote motor development and physical growth in early preterm infants.Trial registrationCHICTR, CTR1900028330, registered December 19, 2019, https:// http://www.chictr.org.cn/showproj.aspx?proj=45706.

Project description:BackgroundPreterm infants are at greater risk for neurodevelopmental disabilities than full term infants. Interventions supporting parents to improve the quality of the infant's environment should improve developmental outcomes for preterm infants. Many interventions that involve parents do not measure parental change, nor is it clear which intervention components are associated with improved parental outcomes. The aim of this review was to categorize the key components of early intervention programs and determine the direct effects of components on parents, as well as their preterm infants.MethodsMEDLINE, EMBASE, CINAHL, ERIC, and Cochrane Database of Systematic Reviews were searched between 1990 and December 2011. Eligible randomized controlled trials (RCTs) included an early intervention for preterm infants, involved parents, and had a community component. Of 2465 titles and abstracts identified, 254 full text articles were screened, and 18 met inclusion criteria. Eleven of these studies reported maternal outcomes of stress, anxiety, depressive symptoms, self-efficacy, and sensitivity/responsiveness in interactions with the infant. Meta-analyses using a random effects model were conducted with these 11 studies.ResultsInterventions employed multiple components categorized as (a) psychosocial support, (b) parent education, and/or (c) therapeutic developmental interventions targeting the infant. All interventions used some form of parenting education. The reporting quality of most trials was adequate, and the risk of bias was low based on the Cochrane Collaboration tool. Meta-analyses demonstrated limited effects of interventions on maternal stress (Z = 0.40, p = 0.69) and sensitivity/responsiveness (Z = 1.84, p = 0.07). There were positive pooled effects of interventions on maternal anxiety (Z = 2.54, p = 0.01), depressive symptoms (Z = 4.04, p <.0001), and self-efficacy (Z = 2.05, p = 0.04).ConclusionsPositive and clinically meaningful effects of early interventions were seen in some psychosocial aspects of mothers of preterm infants. This review was limited by the heterogeneity of outcome measures and inadequate reporting of statistics. IMPLICATIONS OF KEY FINDINGS: Interventions for preterm infants and their mothers should consider including psychosocial support for mothers. If the intervention involves mothers, outcomes for both mothers and preterm infants should be measured to better understand the mechanisms for change.

Project description:BackgroundThis study aims to evaluate the impact of a home-based, post-discharge early intervention (EI) program on reducing parental stress levels in families with preterm infants born between 28+ 0 and 31+ 6 weeks gestational age.MethodsA randomized controlled trial was conducted, with families randomly allocated to either the EI or standard care (SC) group. A term reference group was also recruited for comparison. The Parental Stress Index-Short Form was used to assess parental stress levels, yielding a total stress score and three subdomain scores. Assessment was performed at baseline, at the 60-day mark of the study, and when the infants reached six corrected months of age. Parents in the reference group were assessed only at six months of corrected age for infants. The intervention comprised three sections: intellectual, physical, and social training, which was administered to the infants in the EI group immediately after discharge and to those in the SC group after 60 days of enrollment.ResultsSeventy-three families were enrolled in this study, with 37 allocated to the EI group, and 36 to the SC group. Prior to intervention, higher stress levels were reported by mothers in both groups than fathers, with no difference observed between the EI and SC groups. Re-assessment performed at 60 days of the study showed that mothers and fathers in the EI group had significantly lower total stress score than those in the SC group (82.00 ± 5.64 vs. 94.26 ± 7.99, p < 0.001; 80.74 ± 7.14 vs. 89.94 ± 9.17, p < 0.001, respectively), which was predominantly due to the lower scores in parental distress and parental-child dysfunction interaction subdomains in the EI group (both had p < 0.001). Mothers in the EI group exhibited a more pronounced reduction in total stress score after intervention when compared to fathers (13.15 ± 4.68 vs. 8.26 ± 4.03, p < 0.001). At six months of infant age, the total stress score and subdomain scores of parents in the EI and SC groups were similar, but significantly higher than those of the reference group.ConclusionThe home-based, post-discharge EI program demonstrated significant effectiveness in reducing parental stress levels among the parents of very preterm infants.Trial registrationThis study was registered in the Chinese Clinical Trial Registry (registration number: CTR1900028330). Registration date: December 19, 2019.

Project description:BACKGROUND:It is well documented that heightened levels of parenting stress have a negative influence on children's socio-emotional and behavioral development. Parenting stress may therefore be regarded as an outcome variable in its own right. This study investigated whether a sensitizing intervention influences stress reported by parents of prematurely born children until the children were age nine. METHODS:Preterm infants (N = 146, birth weight <2,000 g) were randomized to intervention (N = 72) with the Mother-Infant Transaction Program (MITP) or a preterm control group (N = 74) that received standard hospital care. A term reference group comprised 75 healthy, full-term neonates. Parents reported on the Parenting Stress Index (PSI) when the children were 6 months, 1, 2, 3, 5, 7 years old and on the PSI-Short Form (PSI-SF) at age 9. Main outcomes were the mother's and father's reports of total, child and parent-related stress. Cross-sectional and longitudinal analyses were performed using linear mixed models (LMM), taking dependency in the data caused by twin pairs and repeated measures into account. Response rates were high across all follow-ups, and still reached 85% from mothers and 72% from fathers at 9 years. RESULTS:Mothers in the intervention group reported better longitudinal development of child-related stress than mothers of preterm controls, as they perceived their children as being more adaptable and less moody throughout childhood until the age of seven. Less stress in the intervention group was revealed by cross-sectional analysis of maternal reports at all ages, while fathers reported similar differences at ages three and five. Parents in the intervention group reported stronger agreement on several stress scores on several occasions. Fathers with high interventional participation (mean 54%) reported significantly less stress at age nine than those who participated less. Both parents in the intervention group reported levels of stress similar to those experienced by the term reference group at all follow-ups, while differences between the preterm control and term reference groups increased. CONCLUSIONS:This early intervention reduces stress among parents of prematurely born children to a level reported by parents of term-born children and enhances agreement between parents. TRIAL REGISTRATION:Clinical Trials Gov identifier NCT00222456, 05.09.2005.

Project description:BackgroundImproved neonatal care has resulted in increased survival rates among infants born after only 22 gestational weeks, but extremely preterm children still have an increased risk of neurodevelopmental delays, learning disabilities and reduced cognitive capacity, particularly executive function deficits. Parent-child interaction and parental mental health are associated with infant development, regardless of preterm birth. There is a need for further early interventions directed towards extremely preterm (EPT) children as well as their parents. The purpose of this paper is to describe the Stockholm Preterm Interaction-Based Intervention (SPIBI), the arrangements of the SPIBI trial and the chosen outcome measurements.MethodsThe SPIBI is a randomized clinical trial that includes EPT infants and their parents upon discharge from four neonatal units in Stockholm, Sweden. Inclusion criteria are EPT infants soon to be discharged from a neonatal intensive care unit (NICU), with parents speaking Swedish or English. Both groups receive three initial visits at the neonatal unit before discharge during the recruitment process, with a strengths-based and development-supportive approach. The intervention group receives ten home visits and two telephone calls during the first year from a trained interventionist from a multi-professional team. The SPIBI intervention is a strengths-based early intervention programme focusing on parental sensitivity to infant cues, enhancing positive parent-child interaction, improving self-regulating skills and supporting the infant's next small developmental step through a scaffolding process and parent-infant co-regulation. The control group receives standard follow-up and care plus extended assessment. The outcomes of interest are parent-child interaction, child development, parental mental health and preschool teacher evaluation of child participation, with assessments at 3, 12, 24 and 36 months corrected age (CA). The primary outcome is emotional availability at 12 months CA.DiscussionIf the SPIBI shows positive results, it could be considered for clinical implementation for child-support, ethical and health-economic purposes. Regardless of the outcome, the trial will provide valuable information about extremely preterm children and their parents during infancy and toddlerhood after regional hospital care in Sweden.Trial registrationThe study was registered in ClinicalTrials.gov in October 2018 (NCT03714633).

Dataset Information

Early Physiotherapy Intervention Program for Preterm Infants and Parents: A Randomized, Single-Blind Clinical Trial.

Background

Methods

Results

Conclusions

Clinicaltrials

Publications

Early Physiotherapy Intervention Program for Preterm Infants and Parents: A Randomized, Single-Blind Clinical Trial.

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