PrematurityNCT05989438
Different Intervention Models of Premature Infants Based on the ICF Biopsychosocial Model
A study testing Orientations for families and Professional stimulation more orientations for families. in people with Prematurity, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
Prematurity is an important risk factor for delayed neuropsychomotor development. The main objective of this study is to analyze the impact of different intervention models on the neuropsychomotor development of premature babies based on the ICF biopsychosocial model. Read more about this study
- Who is it for?
- Ages 4 months to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Prematurity
- What is being tested?
- Orientations for families and Professional stimulation more orientations for families.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2023to 11 Jan 2026
- Phase
- Interventional
- 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 4 months to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Gestational age less than 37 weeks, corrected age between 4 and 12 months (one and a half month window) and at 24 months (four months window)
- Babies from the High Risk Outpatient Clinic of the UCS Clinical Center, registered there;
- Authorization of those responsible for the minor consenting to participation in the study by signing the Free and Informed Consent Form (TCLE).
Who cannot join
- All those subjects who do not follow the items mentioned above;
- Presenting neurological diseases;
- Presence of acute diseases (eg pneumonia, bronchiolitis, trauma)
- Musculoskeletal alterations;
- Genetic syndromes;
- In genetic investigation;
Show all 14Show fewer
- Heart diseases with indication for surgical intervention;
- Untreated congenital torticollis;
- Congenital clubfoot;
- Cerebral hemorrhage grade IV
- Those who do not undergo the first and/or last evaluation;
- Incomplete evaluation;
- Convulsive crisis during study period;
- Participants from other intervention programs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA)
Porto Alegre, Rio Grande do Sul, 90050170
About this study
Official title: Analysis of the Impact of Different Intervention Models on the Neuropsychomotor Development of Premature Infants Based on the ICF Biopsychosocial Model
Prematurity is an important risk factor for delayed neuropsychomotor development. The main objective of this study is to analyze the impact of different intervention models on the neuropsychomotor development of premature babies based on the ICF biopsychosocial model.
Read the detailed description
Premature birth is defined as one in which it occurs before 37 completed weeks of gestation. Prematurity is due to different circumstances, and premature babies can be classified according to gestational age as extremely premature, very premature, or moderately to late preterm. Prematurity is one of the main biological risk factors, and that it contributes to the appearance of changes in the neuropsychomotor development of babies, which may compromise their functional capacity. Thus, screening is essential so that families are guided and premature babies receive adequate early intervention through follow-up programs, mainly aimed at functionality. Given this, and to help standardize health approaches, since 2001 with the development of the biopsychosocial model of health, based on the International Classification of Functioning, Disability and Health (ICF), the use of the ICF is recommended in research and in clinical practice. However, although the use of the ICF in interventions is recommended worldwide, and the literature shows a growing increase in the use of the ICF in studies involving children and young people, there is a shortage of studies, especially in what culminates neuropsychomotor development and prematurity. Thus, the main objective of this study is to analyze the impact of different interventional models on the neuropsychomotor development of premature babies based on the biopsychosocial model of the ICF. This is a randomized, uncontrolled clinical trial, participants will be premature babies with corrected age between 4 and 24 months. Parents of babies who meet the proposed inclusion criteria will be invited to allow participation by signing the Free and Informed Consent term.
The study is composed of two large groups: Stimulation plus Orientations Group and Orientations Group. Participants in both groups will follow the same inclusion and exclusion criteria. Regardless of delay in neuropsychomotor development, during and at the end of each of the three assessments, parents or guardians from both groups received verbal guidance. In addition, in the first evaluation, a printed guide with guidelines for stimulating the baby at home will be given to all families, where the guidelines were divided by months, encompassing from 4 to 24 corrected months.
The guidance guide for families was produced by the researchers emphasizing appropriate stimuli for the corrected age. The guide aims to stimulate neuropsychomotor development, in order to give the baby the opportunity to experiment with new skills, through different postures and transfers, and through facilitation, motor, cognitive, auditory, visual and sensory stimuli. The guidelines prioritize rudimentary postures (prone, supine, lateral decubitus, sitting and standing), in addition to stimuli on cognitive, language, visual and auditory aspects. Parents or guardians will be asked to stimulate their children daily, at the time that is most appropriate for the family's routine, strengthening the bond with the baby. Control of the frequency of performing the stimuli at home will be carried out, the control will be carried out by the families themselves by filling in a column in the guide for information on frequency. The researchers will get in touch with the families in the guidance group once a month to guide and clarify possible doubts, while the families in the guidance plus stimulation group, as they will attend more often than once a month, will have the opportunity to clarify doubts directly with the researcher during the consultations. The researchers will also be available to all families in both groups throughout the entire survey over the phone.
Thinking that we can find families with unfavorable socioeconomic conditions and, also, with the intention of standardizing the stimuli, appropriate toys for each age group will be delivered to all families in the two groups, which will be made by the researchers.
All babies in both groups will participate in a follow-up program where assessments will take place in 4 moments with an interval of 4 months between them on the first year of life (tolerating a window of one month and a half), where: initial assessment, time 1 (t1): 4 corrected months; time 2 (t2): 8 corrected months; time 3 (t3) 12 months corrected; on the time 4 (t4) (will be tolerating a window of four months), 24 months corrected for extreme birth babies (< 28 weeks gestational age) and 24 months cronologic for babies ≥ 28 weeks gestational age. There will be four moments of evaluation that will consist of the analysis of:
- Neuropsychomotor development through the Bayley Infant and Toddler Development Scales, third edition (Bayley III);
- Montreal Cognitive Assessment (MoCA).
- Patient identification data through an evaluation questionnaire and initial anamnesis, information from the health booklet and data from the medical record.
- Affordances in the Home Environment through Affordances in the Home Environment for Motor Development - Children's Scale (AHEMD-IS);
- Quality of life through the Pediatric Inventory on Baby Quality of Life (PedsQL®);
- Socioeconomic data through the Socioeconomic Questionnaire of the Brazilian Research Association (ABEP).
- Parents' cognitive assessment through the Montreal Cognitive Assessment (MoCA).
- Conditions
- Prematurity
- Being tested
- Orientations for families, Professional stimulation more orientations for families.
- Keywords
- Prematurity, Physiotherapy, CIF, Child development, Early Intervention
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orientations for familiesOther
Guidance for parents will follow the guide/manual prepared by the researchers, in addition to verbal and video guidance. Once a week a reminder will be sent, and once a month researchers will contact you by phone for guidance.
There will be 3 evaluations with an interval of 4 months. (4 months; 8 months; 12 months) and more one avaliation with an interval of 12 months at 24 months.
Professional stimulation more orientations for families.Other
Each session will last approximately 50 minutes, where the stimuli will be performed in: supine position; Ventral Decubitus; Seated; Four supports, kneeling/semi-kneeling and standing.
If the child no longer uses the posture or it is not an acquisition for the age group in which the baby is, the time will be distributed in order to contemplate the expected acquisitions for the age group in which the baby is. The stimuli will be performed based on the neuropsychomotor development, in order of progression and according to the corrected age of the baby.
The frequency of consultations may vary due to the different degrees of prematurity, and the stipulated initial frequency will vary between 1-8 times a month.
The orientations will also be provided to family members during consultations, and families will also perform stimuli at home according to written, verbal and video guidance.
There will be 3 evaluations with an interval of 4 months. (4 months; 8 months; 12 months).
| Study group | Role | What they receive |
|---|---|---|
| Premature that the family receives only orientation. | Active comparator | The orientations will happen once a month via telephone, and once a week a reminder will be sent. Follow-up will occur from 4 to 12 corrected months. Receives: Other: Orientations for families |
| Premature who receive intervention by a specialized professional more orientation for the family | Active comparator | The frequency of stimulation by a specialized professional will vary according to the degree of prematurity, from approximately 1 to 8 times per month. The guidelines will take place on the days of the calls. Follow-up will occur from 4 to 12 corrected months. Receives: Other: Professional stimulation more orientations for families. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley III
The Bayley Scales of Infant and Child Development - 3rd Edition, consist of an instrument applied individually to assess the development of children between 1 and 42 months of age and are widely used in research and clinical practice to assess child development. They enable early diagnosis of developmental delays, providing information for planning and intervention. It can be used, for example, to evaluate children, typical, atypical, term or premature. The Bayley-III provides the examiner with the ability to adjust scores for prematurity up to 24 months, which is one of the most notable features of the scale. The adjustment corrects the child's age to his expected chronological age if he had been born at term.
Currently in its third edition, Bayley III presents five distinct subtests for assessing child development in the areas of cognition, language, motor, socio-emotional and adaptive behavior.
Measured: 24 months
Secondary outcomes (4)
Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)
The AHEMD-IS is a validated and reliable instrument for the assessment of infants aged 3 to 18 months. The instrument consists of 35 items divided into 4 dimensions (Physical Space, Variety of Stimulation, Fine Motor Toys and Gross Motor Toys) and a total score that can be categorized into 4 descriptions of domestic motor affordances (scoring system): Insufficient, Moderately Adequate, Adequate and Excellent. The results suggest that this tool can be a useful tool to measure the quantity and quality of affordances in the home environment that favor children's motor development. Researchers will be able to use this instrument to explain this important contributor to children's motor development, as well as for evaluation and intervention recommendations, in addition to advising parents on household activities.
Measured: 24 months
Pediatric Baby Quality of Life Inventory (PedsQL@)
When considering that gains in quality of life in relation to an intervention process are desired outcomes from the perspective of favoring a good health condition, according to the BPS model of the ICF, the Pediatric Inventory on the quality of life of babies presents validity and reliability to be used both in healthy children and those with illnesses or atypical development. It presents versions according to age and health condition. For babies, it presents a version for 1-12 months and another for 13-24 months and is carried out by interviewing parents and/or caregivers. It allows the assessment of quality of life in relation to physical capacity, physical symptoms, emotional aspects, social interaction, cognition and a total score. In cases of specific health conditions or older children, there are specific forms.
Measured: 24 months
Socioeconomic Questionnaire for Brazil
The Socioeconomic Questionnaire for Brazil (ABEP) is a questionnaire used for socioeconomic definition. He reviews all items of appliances that are working, including those that are in storage, or if they are not working, but the family considers fixing or replacing them in 6 months. The points system is composed of the variables: Bathrooms, domestic servants, cars, microcomputer, dishwasher, refrigerator, freezer, washing machine, microwave, motorcycle, clothes dryer (scoring according to the quantity: 0, 1, 2 , 3, 4 or more).
In addition, I evaluate the level of education of the head of the family:
- Illiterate / Incomplete elementary school: 0 points
- Complete Elementary I / Incomplete Elementary II: 1 point
- Complete Elementary II / Incomplete High School: 2 points
- Incomplete Middle School / Incomplete Higher Education: 4 points
- Higher education: 7 points And this instrument also analyzes the conditions of public services for the items: piped
Measured: 24 months
Montreal Cognitive Assessment-MoCA
The MoCA (Montreal Cognitive Assessment) test will be used in this study as a tool for the cognitive assessment of parents, aiming to identify possible changes in cognitive functions, even if subtle. It is a validated and widely used tool in the screening of mild cognitive impairment, offering a comprehensive analysis of skills such as memory, attention, language, executive function and orientation. The application of the MoCA will allow a standardized and objective assessment of the cognitive performance of the participants, contributing to a better understanding of the cognitive profile of the parents in the study sample.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Aug 2023
- Primary completionJun 2025 (estimated)
- Study completion11 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Cechetti, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989438
- Sponsor's protocol ID
- PrematurityICF
- Status last verified
- Jun 2025
- First submitted
- 20 Jul 2023
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Impact of Different Intervention Models on the Neuropsychomotor Development of Premature Infants Based on the ICF Biopsychosocial Model
- ClinicalTrials.gov ID
- NCT05989438
- Acronym / sponsor ID
- PrematurityICF
- Conditions
- Prematurity
- Keywords
- Prematurity, Physiotherapy, CIF, Child development, Early Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- 11 Jan 2026 (estimated)
- First posted
- 14 Aug 2023 (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.
Prematurity is an important risk factor for delayed neuropsychomotor development. The main objective of this study is to analyze the impact of different intervention models on the neuropsychomotor development of premature babies based on the ICF biopsychosocial model.
Detailed description
Premature birth is defined as one in which it occurs before 37 completed weeks of gestation. Prematurity is due to different circumstances, and premature babies can be classified according to gestational age as extremely premature, very premature, or moderately to late preterm. Prematurity is one of the main biological risk factors, and that it contributes to the appearance of changes in the neuropsychomotor development of babies, which may compromise their functional capacity. Thus, screening is essential so that families are guided and premature babies receive adequate early intervention through follow-up programs, mainly aimed at functionality. Given this, and to help standardize health approaches, since 2001 with the development of the biopsychosocial model of health, based on the International Classification of Functioning, Disability and Health (ICF), the use of the ICF is recommended in research and in clinical practice. However, although the use of the ICF in interventions is recommended worldwide, and the literature shows a growing increase in the use of the ICF in studies involving children and young people, there is a shortage of studies, especially in what culminates neuropsychomotor development and prematurity. Thus, the main objective of this study is to analyze the impact of different interventional models on the neuropsychomotor development of premature babies based on the biopsychosocial model of the ICF. This is a randomized, uncontrolled clinical trial, participants will be premature babies with corrected age between 4 and 24 months. Parents of babies who meet the proposed inclusion criteria will be invited to allow participation by signing the Free and Informed Consent term.
The study is composed of two large groups: Stimulation plus Orientations Group and Orientations Group. Participants in both groups will follow the same inclusion and exclusion criteria. Regardless of delay in neuropsychomotor development, during and at the end of each of the three assessments, parents or guardians from both groups received verbal guidance. In addition, in the first evaluation, a printed guide with guidelines for stimulating the baby at home will be given to all families, where the guidelines were divided by months, encompassing from 4 to 24 corrected months.
The guidance guide for families was produced by the researchers emphasizing appropriate stimuli for the corrected age. The guide aims to stimulate neuropsychomotor development, in order to give the baby the opportunity to experiment with new skills, through different postures and transfers, and through facilitation, motor, cognitive, auditory, visual and sensory stimuli. The guidelines prioritize rudimentary postures (prone, supine, lateral decubitus, sitting and standing), in addition to stimuli on cognitive, language, visual and auditory aspects. Parents or guardians will be asked to stimulate their children daily, at the time that is most appropriate for the family's routine, strengthening the bond with the baby. Control of the frequency of performing the stimuli at home will be carried out, the control will be carried out by the families themselves by filling in a column in the guide for information on frequency. The researchers will get in touch with the families in the guidance group once a month to guide and clarify possible doubts, while the families in the guidance plus stimulation group, as they will attend more often than once a month, will have the opportunity to clarify doubts directly with the researcher during the consultations. The researchers will also be available to all families in both groups throughout the entire survey over the phone.
Thinking that we can find families with unfavorable socioeconomic conditions and, also, with the intention of standardizing the stimuli, appropriate toys for each age group will be delivered to all families in the two groups, which will be made by the researchers.
All babies in both groups will participate in a follow-up program where assessments will take place in 4 moments with an interval of 4 months between them on the first year of life (tolerating a window of one month and a half), where: initial assessment, time 1 (t1): 4 corrected months; time 2 (t2): 8 corrected months; time 3 (t3) 12 months corrected; on the time 4 (t4) (will be tolerating a window of four months), 24 months corrected for extreme birth babies (< 28 weeks gestational age) and 24 months cronologic for babies ≥ 28 weeks gestational age. There will be four moments of evaluation that will consist of the analysis of:
- Neuropsychomotor development through the Bayley Infant and Toddler Development Scales, third edition (Bayley III);
- Montreal Cognitive Assessment (MoCA).
- Patient identification data through an evaluation questionnaire and initial anamnesis, information from the health booklet and data from the medical record.
- Affordances in the Home Environment through Affordances in the Home Environment for Motor Development - Children's Scale (AHEMD-IS);
- Quality of life through the Pediatric Inventory on Baby Quality of Life (PedsQL®);
- Socioeconomic data through the Socioeconomic Questionnaire of the Brazilian Research Association (ABEP).
- Parents' cognitive assessment through the Montreal Cognitive Assessment (MoCA).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premature that the family receives only orientation. | Active comparator | Other: Orientations for familiesThe orientations will happen once a month via telephone, and once a week a reminder will be sent. Follow-up will occur from 4 to 12 corrected months. |
| Premature who receive intervention by a specialized professional more orientation for the family | Active comparator | Other: Professional stimulation more orientations for families.The frequency of stimulation by a specialized professional will vary according to the degree of prematurity, from approximately 1 to 8 times per month. The guidelines will take place on the days of the calls. Follow-up will occur from 4 to 12 corrected months. |
Who may qualify
- Ages
- 4 months to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1. Gestational age less than 37 weeks, corrected age between 4 and 12 months (one and a half month window) and at 24 months (four months window)
- Babies from the High Risk Outpatient Clinic of the UCS Clinical Center, registered there;
- Authorization of those responsible for the minor consenting to participation in the study by signing the Free and Informed Consent Form (TCLE).
Key exclusion criteria (14 listed)
- All those subjects who do not follow the items mentioned above;
- Presenting neurological diseases;
- Presence of acute diseases (eg pneumonia, bronchiolitis, trauma)
- Musculoskeletal alterations;
- Genetic syndromes;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orientations for familiesGuidance for parents will follow the guide/manual prepared by the researchers, in addition to verbal and video guidance. Once a week a reminder will be sent, and once a month researchers will contact you by phone for guidance. There will be 3 evaluations with an interval of 4 months. (4 months; 8 months; 12 months) and more one avaliation with an interval of 12 months at 24 months. | Other | Premature that the family receives only orientation. |
| Professional stimulation more orientations for families.Each session will last approximately 50 minutes, where the stimuli will be performed in: supine position; Ventral Decubitus; Seated; Four supports, kneeling/semi-kneeling and standing. If the child no longer uses the posture or it is not an acquisition for the age group in which the baby is, the time will be distributed in order to contemplate the expected acquisitions for the age group in which the baby is. The stimuli will be performed based on the neuropsychomotor development, in order of progression and according to the corrected age of the baby. The frequency of consultations may vary due to the different degrees of prematurity, and the stipulated initial frequency will vary between 1-8 times a month. The orientations will also be provided to family members during consultations, and families will also perform stimuli at home according to written, verbal and video guidance. There will be 3 evaluations with an interval of 4 months. (4 months; 8 months; 12 months). | Other | Premature who receive intervention by a specialized professional more orientation for the family |
Primary outcome
Bayley III
Time frame: 24 months
The Bayley Scales of Infant and Child Development - 3rd Edition, consist of an instrument applied individually to assess the development of children between 1 and 42 months of age and are widely used in research and clinical practice to assess child development. They enable early diagnosis of developmental delays, providing information for planning and intervention. It can be used, for example, to evaluate children, typical, atypical, term or premature. The Bayley-III provides the examiner with the ability to adjust scores for prematurity up to 24 months, which is one of the most notable features of the scale. The adjustment corrects the child's age to his expected chronological age if he had been born at term. Currently in its third edition, Bayley III presents five distinct subtests for assessing child development in the areas of cognition, language, motor, socio-emotional and adaptive behavior.
4 secondary outcomes
Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)
Time frame: 24 months
Pediatric Baby Quality of Life Inventory (PedsQL@)
Time frame: 24 months
Socioeconomic Questionnaire for Brazil
Time frame: 24 months
Montreal Cognitive Assessment-MoCA
Time frame: 24 months
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 25 Jun 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orientations for families and Professional stimulation more orientations for families. in people with Prematurity, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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 3 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 25 Jun 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 Brazil. 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 Fernanda Cechetti, Full professor (+ 55 51 998230-7733, fernandacec@ufcspa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley III (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2025.