Perinatal Risk Factors in Motor Development

NCT07310459 | Not Yet Recruiting

• 1 other identifier: CDIAT Lorca 1/2025
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Premature Infant; Risk Factors; Motor Development of Premature Infants

Outcome Measures

Primary Outcomes (4)

• Perinatal Risk Inventory (PERI)

  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.

  Day 1

• Alberta Infant Motor Scale (AIMS)

  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.

  Baseline

• Gestational age

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

  Day 1

• Birth weight

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

  Day 1

Study Arms (1)

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

Eligibility Criteria

• Age: Up to 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The sample will consist of preterm infants referred to the IDEIC from the Neonatal Service of the Virgen de la Arrixaca University Hospital in Murcia, the Pediatrics Service of the Rafael Méndez University Hospital in Lorca, the Pediatric Service of Health Centers in Lorca area and/or by family referral.

You may qualify if:

• preterm infants showing biological risk factors
• parents or tutors signe an informed consent.

You may not qualify if:

• Diagnosis of encephalopathy
• genetic syndromes
• congenital malformations
• neuromuscular disorders
• myopathies
• metabolic and oncologic diseases

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

CDIAT Fina Navarro Lopez

Lorca, Murcia, 30800, Spain

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Francisco Javier Fernandez Rego, PhD

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco Javier Fernandez Rego, PhD

CONTACT

+34 666557827; fjfernan@um.es

Galaad Torro Ferrero, PhD

CONTACT

+34 685306937; galaad.torro@um.es

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: December 30, 2025
• Study Start: February 1, 2026
• Primary Completion: February 28, 2026
• Study Completion: April 30, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: indefinitely from the publication of the study
• Access Criteria: Proper request to the authors.

Locations

ES (1)