Premature InfantNCT07310459
Perinatal Risk Factors in Motor Development
An observational study of Premature Infant and Risk Factors, run by Universidad de Murcia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 months
- Conditions the study is for
- Premature Infant, Risk Factors, Motor Development of Premature Infants
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2026to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- preterm infants showing biological risk factors
- parents or tutors signe an informed consent.
Who cannot join
- Diagnosis of encephalopathy
- genetic syndromes
- congenital malformations
- neuromuscular disorders
- myopathies
- metabolic and oncologic diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
CDIAT Fina Navarro Lopez
Lorca, Murcia, 30800
Francisco Javier Fernandez Rego, PhD, +34968467499, cdiatlorca@lorca.es
+34
About this study
Official title: Evaluation of Perinatal Risk Factors in Future Gross Motor Development of Preterm Infants: a Cross-sectional Study
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).
Read the 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.
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Gestational age
Gestational age at birth. This information will be extracted from their discharge medical records
Measured: Day 1
Birth weight
Weight that preterm infant had at birth. This information will be extracted from their discharge medical records
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Feb 2026 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier Fernandez Rego, Universidad de Murcia
- Investigators
- Francisco Javier Fernandez Rego, PhD, Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310459
- Sponsor's protocol ID
- CDIAT Lorca 1/2025
- Status last verified
- Nov 2025
- First submitted
- 22 Apr 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared upon justified request to the authors.
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.
PubMed 24304976Zaramella 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.
PubMed 17897797Thomaidis 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.
PubMed 24521451Christian 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.
PubMed 24575933
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perinatal Risk Factors in Future Gross Motor Development of Preterm Infants: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07310459
- Acronym / sponsor ID
- CDIAT Lorca 1/2025
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- preterm infants showing biological risk factors
- parents or tutors signe an informed consent.
Key exclusion criteria (6 listed)
- Diagnosis of encephalopathy
- genetic syndromes
- congenital malformations
- neuromuscular disorders
- myopathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Gestational age
Time frame: Day 1
Gestational age at birth. This information will be extracted from their discharge medical records
Birth weight
Time frame: Day 1
Weight that preterm infant had at birth. This information will be extracted from their discharge medical records
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Background: PubMed 24304976Pritchard 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.
- Background: PubMed 17897797Zaramella 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.
- Background: PubMed 24521451Thomaidis 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.
- Background: PubMed 24575933Christian 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.
- Individual participant dataSharing planned: Yes. The data will be shared upon justified request to the authors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francisco Javier Fernandez Rego, PhD principal investigator
Universidad de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Infant and Risk Factors, run by Universidad de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco Javier Fernandez Rego, PhD (+34 666557827, fjfernan@um.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perinatal Risk Inventory (PERI) (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07310459, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.