Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
160 participants
OBSERVATIONAL
2026-02-01
2026-04-30
Brief Summary
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We will compare the data of infants evaluated by the Alberta Infant Motor Scale (AIMS) and the Perinatal Risk Inventory (PERI) in an Infant Development and Early Intervention Center (IDEIC).
Detailed Description
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The gestational age of each infant will be recorded and used to group participants according to the following classification: late preterm newborn infant (LPNI; born between 34+1 and 36+6 weeks of gestation); moderate preterm newborn infant (MPNI; born between 32+1 to 34 weeks of gestation); very preterm newborn infant (VPNI; born between 28 to 32 weeks of gestation); and extreme preterm newborn infant (EPNI; born before 28 weeks of gestation).
The birth weight will be recorded and the infants will be grouped according to the following classification: newborns with adequate birth (birth weight of \>2500 g), low birth weight (LBW; \<2500 g and \>1500 g); very low birth weight (VLBW; \<2500 g and \>1000 g), and extreme low birth weight (ELBW; \<1000 g).
The infants will be assessed by the PERI test accounting for their discharge medical records. The infants will be then classified according to the biological risk level, in low, moderate and high risk.
Both the PERI and the AIMS test were assessed by three physiotherapists from the IDEIC with 10 to 20 years of experience.
Afterwards data will be analyzed using the Statistical Package for the Social Sciences Statistics (IBM SPSS) software for Windows version 22.0.
From all data collected as described in the brief summary, descriptive analysis and correlations between variables will be performed.
Samples will be classified using descriptive and frequency analysis. One-factor ANOVA, bivariate correlations will be carried out. Correlations between variables will be evaluated using Pearson's coefficient (bivariate correlation) or Spearman's coefficient (rank correlation). Frequencies analysis, square Chi test and backwards regression analysis will be used when appropriate.
AIMS direct scores will be standardized by converting them into Z scores. AIMS standard mean and deviation by age and gender will be used.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Group of Preterm infants
Preterm infants cared at the "Fina Navarro Lopez" Childhood Development and Early Intervention Center (Lorca) between 2023 and 2025 who have been assessed using the Alberta Infant Motor Scale and the Perinatal Risk Inventory
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* parents or tutors signe an informed consent.
Exclusion Criteria
* genetic syndromes
* congenital malformations
* neuromuscular disorders
* myopathies
* metabolic and oncologic diseases
18 Months
ALL
No
Sponsors
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Universidad de Murcia
OTHER
Responsible Party
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Francisco Javier Fernandez Rego
Doctor
Principal Investigators
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Francisco Javier Fernandez Rego, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de Murcia
Locations
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CDIAT Fina Navarro Lopez
Lorca, Murcia, Spain
Countries
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Central Contacts
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Facility Contacts
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Francisco Javier Fernandez Rego, PhD
Role: primary
+34
Role: backup
References
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Pritchard MA, Colditz PB, Cartwright D, Gray PH, Tudehope D, Beller E. Risk determinants in early intervention use during the first postnatal year in children born very preterm. BMC Pediatr. 2013 Dec 5;13:201. doi: 10.1186/1471-2431-13-201.
Zaramella P, Freato F, Milan A, Grisafi D, Vianello A, Chiandetti L. Comparison between the perinatal risk inventory and the nursery neurobiological risk score for predicting development in high-risk newborn infants. Early Hum Dev. 2008 May;84(5):311-7. doi: 10.1016/j.earlhumdev.2007.08.003. Epub 2007 Sep 27.
Thomaidis L, Zantopoulos GZ, Fouzas S, Mantagou L, Bakoula C, Konstantopoulos A. Predictors of severity and outcome of global developmental delay without definitive etiologic yield: a prospective observational study. BMC Pediatr. 2014 Feb 12;14:40. doi: 10.1186/1471-2431-14-40.
Christian P, Murray-Kolb LE, Tielsch JM, Katz J, LeClerq SC, Khatry SK. Associations between preterm birth, small-for-gestational age, and neonatal morbidity and cognitive function among school-age children in Nepal. BMC Pediatr. 2014 Feb 27;14:58. doi: 10.1186/1471-2431-14-58.
Other Identifiers
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CDIAT Lorca 1/2025
Identifier Type: -
Identifier Source: org_study_id