Apr 02, 2026
Study Protocol: Growing up Preterm in the Algarve Region
- Ana Tomé1,2,3,
- Elsa Silva4
- 1Universidade do Algarve;
- 2Center for Innovative Care and Health Technology;
- 3Unidade Local de Saúde do Algarve - Hospital de Faro;
- 4Unidade Local de Saude do Algarve - Hospital Faro
- Ana Tomé
Protocol Citation: Ana Tomé, Elsa Silva 2026. Study Protocol: Growing up Preterm in the Algarve Region. protocols.io https://dx.doi.org/10.17504/protocols.io.j8nlkzrz5l5r/v1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: March 16, 2026
Last Modified: April 02, 2026
Protocol Integer ID: 313297
Keywords: Prematurity; Preterm infants; Neonatolog...
Disclaimer
This protocol describes a retrospective observational research methodology based on the consultation of anonymized hospital records. It is intended exclusively for research and educational purposes. The protocol does not constitute clinical guidance and should not replace professional medical judgment or institutional procedures. The implementation of this study must comply with all applicable ethical regulations and requires approval from the appropriate institutional and ethics committees. The authors are not responsible for any misuse or misinterpretation of the procedures described in this protocol.This study is promoted by Associação Nascer Prematuro
Abstract
Premature birth is associated with an increased risk of neuromotor, sensory, cognitive, and socio-emotional difficulties that may compromise child development and later academic performance. Children born prematurely frequently present vulnerabilities related to learning difficulties, reduced inhibitory control, slower information processing, fine motor and visuomotor integration problems, sensory processing alterations, and language impairments. These developmental challenges may negatively affect school readiness and achievement, particularly in areas requiring complex cognitive skills such as mathematical reasoning. Additionally, premature children show a higher prevalence of behavioral and social difficulties, including characteristics associated with the autism spectrum. It is estimated that between 20% and 30% of very premature children develop moderate to severe cognitive difficulties, which can persist into adolescence and adulthood and may have long-term social, educational, and economic consequences. Increasing awareness among education professionals and strengthening early intervention strategies are therefore essential to support this vulnerable population.
This study aims to characterize children born prematurely at the Centro Hospitalar Universitário do Algarve (CHUA) – Faro Unit and to identify their geographic distribution within the Algarve region in order to support the planning of targeted awareness and training initiatives for professionals working in early childhood education.
An observational, retrospective, cross-sectional, non-pharmacological study will be conducted through the retrospective review of hospitalization records. Data will be collected by the responsible investigator through consultation of clinical records available on the hospital’s clinical information platforms, with administrative or IT support when necessary. The study sample includes newborns born before 35 weeks of gestation and admitted to the Neonatal Intensive Care Unit of CHUA – Faro Unit between January 1, 2019, and September 30, 2023. Cases admitted to neonatology for reasons unrelated to prematurity will be excluded.
Descriptive statistical analysis will be performed using socio-demographic and hospitalization data, including municipality of residence, date of birth, gestational age, reason for hospitalization, length of stay, birth weight, and discharge weight. No clinical diagnostic data will be analyzed.
The study will comply with the ethical principles of the Declaration of Helsinki and will be conducted only after approval from the CHUA Administration Board, the Neonatal and Pediatric Intensive Care Service Directorate, and the CHUA Ethics Committee. Due to the retrospective nature of the study and the use of anonymized data, informed consent from parents will not be required. All data will be anonymized, and no information capable of identifying individuals will be collected. The results are expected to support the development of awareness actions and professional training initiatives aimed at improving early identification of developmental risks and strengthening educational support for children born prematurely in the Algarve region.
The characterization of children born prematurely at the Centro Hospitalar Universitário do Algarve – Faro Unit, together with the identification of their geographical distribution across the Algarve region, is expected to provide a clearer understanding of the regional dimension of prematurity. The analysis of these data may contribute to defining priorities for the implementation of awareness and training initiatives aimed at education professionals and early intervention specialists, particularly in areas with a higher concentration of prematurely born children. Furthermore, the results of this study may support the development of preventive strategies, facilitate the early identification of psychomotor developmental risk factors, and promote more appropriate educational responses, ultimately contributing to better inclusion and academic trajectories for children born prematurely.
Troubleshooting
Study Protocol
Retrospective observational study, non-pharmacological cross-sectional.
Introduction
Children born prematurely are at risk of developing neuromotor, sensory, psychological, and social conditions inherent to premature birth that can potentially compromise their development. These conditions often involve risks associated with learning difficulties, decreased academic performance, and the consequent need for special educational intervention. Prematurity is a major factor, but children who are born with low birth weight, brain injury, bronchopulmonary dysplasia, as well as social factors such as low parental education, lack of parental responsiveness and effective support, and some risks associated with minority and marginalized ethnicities, further exacerbate the vulnerability these children face. In the situations described above, there is a high probability of specific problems arising such as attention deficits, low inhibitory control, decreased processing speed, difficulties in fine motor skills and visual-motor integration, sensory processing difficulties, and language problems. These cognitive skills are extremely important for learning and academic performance, which may be compromised, as well as the child's competencies in formal education, in meeting established school curricula, especially in the domain of mathematical reasoning. It is also worth noting the high incidence of behavioral and social changes within the autism spectrum among these children. Between 20 to 30% of very premature children present moderate to severe cognitive difficulties. These difficulties have a high economic and social cost, reflecting both in school difficulties and future job access, with undeniable repercussions on the mental health of young people and adults. Moreover, there are various studies that attest to the fact that cognitive and academic difficulties of very premature children persist into adolescence and adulthood. This study aims to contribute to the development of awareness actions (for education professionals who will support these children) regarding the issue of prematurity in education and the development of premature children, as well as to contribute to training in the field of intervention with premature children in the context of the public preschool network in areas where there is a higher number of prematurely born children, or where there is willingness and acceptance on the part of schools/social support networks to these children. Additionally, we aim to use the collected data to plan and propose training and education initiatives to sensitize professionals working with these children to identify risk factors for the psychomotor development of these children.
Methods
Retrospective review of hospital admission records and data
The data will be collected by the responsible researcher from Unidade Local de Saúde do Algarve or the principal investigator, through the consultation of records and hospitalization data, including residence data (residence council) in the Clínico platform, or another platform/software with the support of administrative or IT services..
The records will be provided by the hospital unit's own services.
Sample
Newborn babies (premature babies born before 35 weeks of gestation) admitted to the Neonatal Intensive Care Unit at ULS Hospital de Faro Unit.
Inclusion criteria
All individuals (newborn children) born prematurely before 35 weeks of gestation, admitted to the Neonatal Intensive Care Unit of CHUA in Faro, from January 1, 2019 to September 30, 2023, will be included.
Exclusion criteria
All individuals admitted to the neonatology unit, whose reason for admission is not related to prematurity.
Results
The results of the collected data will be analyzed descriptively. Only data related to the socio-demographic situation will be collected, such as residence (place of residence), date of birth, gestational age, reason for hospitalization, length of hospital stay, birth weight, and discharge weight. From a clinical perspective, it is not the objective of this study to collect or analyze any data related to the clinical situation of the children..
Ethical proceedings
This study will respect all ethical issues outlined in the Helsinki Declaration. It will only be conducted with authorization from the ULS Board of Directors and the Director of the Neonatal and Pediatric Intensive Care Service at ULS Algarve-Faro Hospital Unit Unit. Due to the nature of the study, there is no requirement for parental consent to access the data. However, the study will only proceed after approval from the ULS Ethics Committee. The collected data will be anonymized and no information that could identify individuals will be used. The data will only be used for this study and related research. Identifying information of individuals whose data is accessed will not be collected, and their anonymization will be respected.
Protocol references
1- European Standards of Care for the Newborn Health, Meeting Special Needs at School. Autores: Jaekel L, Johnson S W D, van Wassenaer-Leemhuis A. EFCNI, 2024
2- Pierrat V, Marchand-Martin L, Arnaud C, Kaminski M, Resche-Rigon M, Lebeaux C, Bodeau-Livinec F, Morgan AS, Goffinet F, Marret S, Ancel PY; EPIPAGE-2 writing group. Neurodevelopmental outcome at 2 years for preterm children born at 22 to 34 weeks' gestation in France in 2011: EPIPAGE-2 cohort study. BMJ. 2017 Aug 16;358:j3448. doi: 10.1136/bmj.j3448. PMID: 28814566; PMCID: PMC5558213.
3- Guellec I, Lapillonne A, Renolleau S, Charlaluk ML, Roze JC, Marret S, Vieux R, Monique K, Ancel PY; EPIPAGE Study Group. Neurologic outcomes at school age in very preterm infants born with severe or mild growth restriction. Pediatrics. 2011 Apr;127(4):e883-91. doi: 10.1542/peds.2010-2442. Epub 2011 Mar 7. PMID: 21382951.
4- Larroque B, Ancel PY, Marchand-Martin L, Cambonie G, Fresson J, Pierrat V, Rozé JC, Marpeau L, Thiriez G, Alberge C, Bréart G, Kaminski M, Marret S; Epipage Study group. Special care and school difficulties in 8-year-old very preterm children: the Epipage cohort study. PLoS One. 2011;6(7):e21361. doi: 10.1371/journal.pone.0021361. Epub 2011 Jul 8. PMID: 21760892; PMCID: PMC3132214.
5- Delobel-Ayoub M, Arnaud C, White-Koning M, Casper C, Pierrat V, Garel M, Burguet A, Roze JC, Matis J, Picaud JC, Kaminski M, Larroque B; EPIPAGE Study Group. Behavioral problems and cognitive performance at 5 years of age after very preterm birth: the EPIPAGE Study. Pediatrics. 2009 Jun;123(6):1485-92. doi: 10.1542/peds.2008-1216. PMID: 19482758.