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NCT Number: NCT07310459

Perinatal Risk Factors in Motor Development

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).

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Key information

Conditions

Premature Infant Female Urogenital Diseases and Pregnancy Complications Motor Development of Premature Infants Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Risk Factors Urogenital Diseases

Age range

Up to 18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

CDIAT Fina Navarro Lopez

Lorca, Murcia, 30800, Spain

Location contact

+34

CONTACT

Francisco Javier Fernandez Rego, PhD

CONTACT

[email protected]

+34968467499

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Perinatal Risk Inventory (PERI)

    Time frame: Day 1

    The PERI is a test designed to assess neonatal situation, prior to infants' discharge from the hospital at birth that determines the possibility of abnormalities or pathologies in the infant' development at very early stages. Its predictive value is greater when it reaches a score equal or superior to 10.

    The infants will be assessed by the PERI test accounting using their discharge medical records.

  2. Alberta Infant Motor Scale (AIMS)

    Time frame: Baseline

    The Alberta Infant Motor Scale (AIMS) is an observational scale to assess infants' gross motor development from birth to independent walking. The test consists of 58 items based on descriptions of the postural control in supine (9 items), prone (21 items), sitting (12 items) and standing (16 items) position. Each item scores one point, therefore the maximum puntuation possible is 58 points and the minimum 0 points. The greater the puntuation, the better is their motor development.

    It is conceived for infants from 0 to 18 months old. The test provides information about the infant's motor activities and allows the measurement of motor activity development over time or before and after therapy. The infants' assessment needs to take place in a quiet environment with minimal handling and without stimuli or random help. An assessment of the infants' gross motor development will be carried out at admission, following the AIMS scale and bearing in mind their corrected age.

  3. Gestational age

    Time frame: Day 1

    Gestational age at birth. This information will be extracted from their discharge medical records

  4. Birth weight

    Time frame: Day 1

    Weight that preterm infant had at birth. This information will be extracted from their discharge medical records

Study contacts

Contact information is provided by the study sponsor or research team.

Francisco Javier Fernandez Rego, PhD

CONTACT

[email protected]

+34 666557827

Galaad Torro Ferrero, PhD

CONTACT

[email protected]

+34 685306937

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

Evaluation of Perinatal Risk Factors in Future Gross Motor Development of Preterm Infants: a Cross-sectional Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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