Premature BirthNCT04563364
Interdisciplinary Hospital-home Intervention on Motor Development in Premature Children
A study testing Interdisciplinary hospital-home intervention and Convencional treatment in people with Premature Birth, run by Universidad de la Sabana at 1 site in Colombia.
Trial summary
Motor development of the premature infant often exhibits deviations that trigger functional limitations and disability. In Colombia, one out of every five births corresponds to premature babies. Read more about this study
- Who is it for?
- Ages 34 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Interdisciplinary hospital-home intervention and Convencional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteColombia
- Study dates
- 1 Oct 2021to 29 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 34 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Premature infants between 34 and 37 weeks of gestation,
- Infants with weight over 1800gr
- Hemodynamic stability
- Interns in NICU of participants institutions (Colombia and Poland).
- Infants with residence in a places close to the institutional health care services.
Who cannot join
- Premature child with a musculoskeletal deformity.
- Premature child with diagnosis of a genetic syndrome
- Premature child with congenital heart diseases.
- Premature child with brain injuries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interdisciplinary Hospital-home Intervention on the Adaptation of Motor Development in Premature Children.Randomized Clinical Trial
Motor development of the premature infant often exhibits deviations that trigger functional limitations and disability. In Colombia, one out of every five births corresponds to premature babies. In preterm infants requiring hospitalization, early clinical interventions focused on home care have been shown to improve motor development and decrease morbidity.
However, interdisciplinary work, supported by information and communication Technologies (ICT), shows a knowledge gap that can be explored. This leads to the following research question: ¿What is the effect of an interdisciplinary Hospital-Home intervention addressing motor development adaptation in premature infants in Colombia in comparison with traditional interventions?
Read more
Objective: To determine the effect of an interdisciplinary Hospital-Home intervention addressing motor development adaptation in premature infants in Colombia in comparison with traditional interventions
Methodology Experimental quantitative study with pre-test and post-test to two groups, experimental and control, which compares before and after the intervention. The intervention will be developed in two scenarios: the hospital and the home. The experimental group will receive the intervention and the control group the traditional care established in the institutions for premature children. The calculation of the sample size is 130 participants.
Type of results expected to be obtained It is expected to obtain a supported that justifies the importance of education from hospital stay, post discharge follow-up and parental participation in the adequate stimulation of motor development of the premature. It is expected to incorporate the use of ICT in home monitoring, while implementing the use of a mobile application for this purpose. It is also expected to contribute to the research training of undergraduate and graduate students. In addition, participate in national and international presentations and in the production of scientific articles.
- Conditions
- Premature Birth
- Being tested
- Interdisciplinary hospital-home intervention, Convencional treatment
- Keywords
- Infant, Child Development, Nursing, Physical Therapy Specialty
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary hospital-home interventionOther
The intervention will start in NICU and to be continued at home with the support of ICT. The NICU intervention will have theoretical and practical components, the theoretical one will be about motor development in premature infants, and practical one will have strategies for motor early intervention, it will be demonstrated with pediatric simulator and parents should be demonstrate it with a infant: 1Sensorial motor stimulation, visual and auditory follow-6up; Tactile integration 3Extension muscle activation 4Middle line integration 5Alignment reaction stimulation in prone position 6Flexor muscle activation with transition to lateral position 7Flexor muscle activation with transition to sitting position 8Facilitation of reciprocal flexion and extension lower limbs. All parents will receive a motor sensorial kit that will include roller, visual tags, blankets and rattles, it will be for apply the strategies for motor early intervention, and will be supported by ICT
Convencional treatmentOther
Control group will receive a conventional treatment given by the institutions
| Study group | Role | What they receive |
|---|---|---|
| Hospital-Home | Experimental | This group will receive an interdisciplinary intervention of education to parents for get better outcomes of motor development. Receives: Other: Interdisciplinary hospital-home intervention |
| Control Intervention | Active comparator | Control group will receive a conventional treatment given by the institutions Receives: Other: Convencional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Development.
Test on infant motor performance (TIMPSI)
Measured: 18 Months
Secondary outcomes (1)
CapDMP questionnaire
Questionnaire that measure the degree of knowledge in parents or caregivers about motor development in premature
Measured: From enrollment to the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Oct 2021
- Primary completion15 Mar 2023
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de la Sabana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adriana L Castellanos, Mg., Principal investigator, Universidad de la Sabana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563364
- Sponsor's protocol ID
- ENF-32-2019
- Status last verified
- Mar 2025
- First submitted
- 25 Aug 2020
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sandoval-Cuellar C, Castellanos-Garrido AL, Ospina Romero AM, Boude Figueredo OR, Serrano-Gomez ME, Fuya Caro CA, Molina Cardenas DC, Pinto Rosas EM. Motor development in premature infants: Study protocol for an interdisciplinary hospital-home intervention. Pediatr Neonatol. 2023 Sep;64(5):577-584. doi: 10.1016/j.pedneo.2022.12.015. Epub 2023 Mar 15.
PubMed 37002053
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Hospital-home Intervention on the Adaptation of Motor Development in Premature Children.Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04563364
- Acronym / sponsor ID
- ENF-32-2019
- Conditions
- Premature Birth
- Keywords
- Infant, Child Development, Nursing, Physical Therapy Specialty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Universidad de la SabanaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 24 Sep 2020 (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.
Motor development of the premature infant often exhibits deviations that trigger functional limitations and disability. In Colombia, one out of every five births corresponds to premature babies. In preterm infants requiring hospitalization, early clinical interventions focused on home care have been shown to improve motor development and decrease morbidity.
However, interdisciplinary work, supported by information and communication Technologies (ICT), shows a knowledge gap that can be explored. This leads to the following research question: ¿What is the effect of an interdisciplinary Hospital-Home intervention addressing motor development adaptation in premature infants in Colombia in comparison with traditional interventions?
Objective: To determine the effect of an interdisciplinary Hospital-Home intervention addressing motor development adaptation in premature infants in Colombia in comparison with traditional interventions
Methodology Experimental quantitative study with pre-test and post-test to two groups, experimental and control, which compares before and after the intervention. The intervention will be developed in two scenarios: the hospital and the home. The experimental group will receive the intervention and the control group the traditional care established in the institutions for premature children. The calculation of the sample size is 130 participants.
Type of results expected to be obtained It is expected to obtain a supported that justifies the importance of education from hospital stay, post discharge follow-up and parental participation in the adequate stimulation of motor development of the premature. It is expected to incorporate the use of ICT in home monitoring, while implementing the use of a mobile application for this purpose. It is also expected to contribute to the research training of undergraduate and graduate students. In addition, participate in national and international presentations and in the production of scientific articles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital-Home | Experimental | Other: Interdisciplinary hospital-home interventionThis group will receive an interdisciplinary intervention of education to parents for get better outcomes of motor development. |
| Control Intervention | Active comparator | Other: Convencional treatmentControl group will receive a conventional treatment given by the institutions |
Who may qualify
- Ages
- 34 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Premature infants between 34 and 37 weeks of gestation,
- Infants with weight over 1800gr
- Hemodynamic stability
- Interns in NICU of participants institutions (Colombia and Poland).
- Infants with residence in a places close to the institutional health care services.
Key exclusion criteria (4 listed)
- Premature child with a musculoskeletal deformity.
- Premature child with diagnosis of a genetic syndrome
- Premature child with congenital heart diseases.
- Premature child with brain injuries.
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 |
|---|---|---|
| Interdisciplinary hospital-home interventionThe intervention will start in NICU and to be continued at home with the support of ICT. The NICU intervention will have theoretical and practical components, the theoretical one will be about motor development in premature infants, and practical one will have strategies for motor early intervention, it will be demonstrated with pediatric simulator and parents should be demonstrate it with a infant: 1Sensorial motor stimulation, visual and auditory follow-6up; Tactile integration 3Extension muscle activation 4Middle line integration 5Alignment reaction stimulation in prone position 6Flexor muscle activation with transition to lateral position 7Flexor muscle activation with transition to sitting position 8Facilitation of reciprocal flexion and extension lower limbs. All parents will receive a motor sensorial kit that will include roller, visual tags, blankets and rattles, it will be for apply the strategies for motor early intervention, and will be supported by ICT | Other | Hospital-Home |
| Convencional treatmentControl group will receive a conventional treatment given by the institutions | Other | Control Intervention |
Primary outcome
Motor Development.
Time frame: 18 Months
Test on infant motor performance (TIMPSI)
1 secondary outcome
CapDMP questionnaire
Time frame: From enrollment to the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 37002053Sandoval-Cuellar C, Castellanos-Garrido AL, Ospina Romero AM, Boude Figueredo OR, Serrano-Gomez ME, Fuya Caro CA, Molina Cardenas DC, Pinto Rosas EM. Motor development in premature infants: Study protocol for an interdisciplinary hospital-home intervention. Pediatr Neonatol. 2023 Sep;64(5):577-584. doi: 10.1016/j.pedneo.2022.12.015. Epub 2023 Mar 15.
- 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. This study is not recruiting at the moment.
Adriana L Castellanos, Mg. principal investigator
Universidad de la Sabana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdisciplinary hospital-home intervention and Convencional treatment in people with Premature Birth, run by Universidad de la Sabana at 1 site in Colombia.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 30 Mar 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 Colombia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Development. (time frame: 18 Months). 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 NCT04563364, which also lists 1 linked publication.
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 Mar 2025.