Perinatal Risk Factors in Motor Development

Universidad de Murcia

Status: Not yet enrolling

Conditions: Motor Development of Premature Infants; Risk Factors; Premature Infant

Study type: Observational

Funder types: Other

Identifiers

NCT07310459

CDIAT Lorca 1/2025

Details and patient eligibility

About

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).

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: Under 18 months old

Volunteers: No Healthy Volunteers

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

Trial design

160 participants in 1 patient group

Group of Preterm infants

Description:

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