Perinatal Risk Factors in Motor Development
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Premature Infant, Risk Factors, Motor Development of Premature Infants. Basic parameters: up to 18 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Perinatal Risk Factors in Future Gross Motor Development of Preterm Infants: a Cross-sectional Study
Overview
The aim of this study is to analyze the effect of preterm gestational age, birth weight and perinatal risks factors on gross motor development of preterm infants. 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
An assessment of the infants' gross motor development will be carried out at admission, of IDEIC following the AIMS scale and bearing in mind their corrected age. Importantly, the trimester according to their corrected age was also recorded.
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.
Primary outcome measures
- Perinatal Risk Inventory (PERI) [Time frame: Day 1]
- Alberta Infant Motor Scale (AIMS) [Time frame: Baseline]
- Gestational age [Time frame: Day 1]
- Birth weight [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- preterm infants showing biological risk factors
- parents or tutors signe an informed consent.
Exclusion criteria
- Diagnosis of encephalopathy
- genetic syndromes
- congenital malformations
- neuromuscular disorders
- myopathies
- metabolic and oncologic diseases
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Spain · 1 center
- CDIAT Fina Navarro Lopez — Lorca
Publications
- 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. PMID 24304976
- 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. PMID 17897797
- 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. PMID 24521451
- 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. PMID 24575933
Identifiers
NCT: NCT07310459 · CDIAT Lorca 1/2025