Growth AlterationNCT07515248
Catch up Growth Of Children After Closure Of Hemodinamically Significant Large VSD In Assuit University Children Hospital
An observational study of Growth Alteration, run by Assiut University at 1 site in Egypt.
Trial summary
The primary objective of this study is to evaluate the patterns of catch-up growth in children following the closure of large VSDs. Specific Objectives: To measure anthropometric changes (Weight, Height/Length, and BMI) pre- and post-closure. Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Growth Alteration
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2026to Apr 2028
- 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 1 month to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: The population includes: Age group: Infants and young children aged from 1 month up to 2 years. Clinical Status: Patients presenting with symptoms of congestive heart failure and Failure to Thrive (FTT) due to the left-to-right shunt. Surgical Status: Patients who are candidates for and undergo successful surgical or interventional closure of the defect. Nutritional Status: Children exhibiting pre-operative growth retardation (low weight-for-age or height-for-age Z-scores) specifically related to their cardiac condition.
Who may be able to join
- Children diagnosed with isolated large VSD meeting the following criteria:
- Age from 1 month to 2 years old
- Symptomatic patient with hemodynamically significant VSD by echocardiography who is candidate for closure.
- Patients with pre-operative growth retardation
- Patients undergoing successful closure
Who cannot join
- Associated complex heart lesions or cyanotic CHD (e.g., Tetralogy of Fallot).
- Genetic syndromes affecting growth (e.g., Down syndrome , Turner syndrome)
- Major extra-cardiac malformations or chronic systemic diseases (e.g., Renal failure,liver disease, metabolic disorder, Celiac disease).
- Preoperative malnutrition unrelated to cardiac disease (e.g., malabsorption syndromes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University Children Hospital
Asyut, Asyut Governorate, 71515
Faten S Nashed, Master Degree in Pediatrics, +201150156184, fatensamirmalak@gmail.com
About this study
The primary objective of this study is to evaluate the patterns of catch-up growth in children following the closure of large VSDs.
- Specific Objectives:
- To measure anthropometric changes (Weight, Height/Length, and BMI) pre- and post-closure.
- To determine the time interval required to reach normal growth percentiles for age and sex.
- To identify predictors of poor growth recovery (e.g., age at intervention, baseline nutritional status, or residual shunts).
Read the detailed description
Ventricular septal defect (VSD) is the most common congenital heart disease, representing 30% to 50% of cardiac malformations at birth. It can lead to pulmonary hypertension and congestive heart failure. A hallmark clinical manifestation in these children is Failure to Thrive (FTT). The growth failure is multifactorial, resulting from increased metabolic demands (tachycardia and increased respiratory effort), inadequate caloric intake due to fatigue during feeding, chronic tissue hypoxia, and frequent lower respiratory tract infections.
Surgical closure eliminates the left-to-right shunt; restoring hemodynamic stability, reducing energy demands, improving feeding tolerance, and providing a substrate for growth recovery. Surgical correction in the first months of life is the current option for most large VSDs, as it provides complete resolution of the cardiac anomaly, with earlier control of heart failure, allowing for earlier cardiovascular drug weaning.
Although low weight at the time of repair is a known risk factor for morbidity and mortality, early surgery leads to a more favorable growth pattern. In fact, growth normalization of infants with VSD and normal birth weight who underwent primary surgical closure before the first year of life has been documented. Some reports emphasize the importance of early surgical repair for the best growth patterns in these infants. These benefits have also been observed in low birth weight infants, although with more limited growth acceleration, probably due to an early intrauterine insult. Early surgery also provides a shorter period of time at risk of heart failure complications, including respiratory infections, need for medication, and hospitalization. However, in some centers, surgery is delayed until a higher weight is achieved to reduce operative risks. The phenomenon of catch-up growth-an acceleration of growth following removal of the growth-limiting condition-is well-described in pediatric surgical literature but varies in magnitude and timing after VSD closure.
The study aims at establishing the pattern of catch-up growth in infants who have undergone surgical repair of VSD before 1 year of age and comparing it with the reference population. The research also evaluates the influence of the severity of preoperative growth failure on the postoperative growth pattern in term and preterm infants.
- Conditions
- Growth Alteration
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight-for-Age Z-score (WAZ)
Assessment of catch-up growth by measuring the change in Weight-for-Age Z-scores.
Measured: Baseline, 6, 12, and 18 months post-closure.
Change in Height-for-Age Z-score (HAZ)
Assessment of catch-up growth by measuring the change in Height-for-Age Z-scores
Measured: Baseline, 6, 12, and 18 months post-closure.
Change in Weight-for-Height Z-score (WHZ
Assessment of catch-up growth by measuring the change in Weight-for-Height Z-scores.
Measured: Baseline, 6, 12, and 18 months post-closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Growth AlterationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faten Samir Malak Nashed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515248
- Sponsor's protocol ID
- Catch up Growth Of Children
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Doki Y, Nakazawa Y, Sukegawa M, Petrova RS, Ishida Y, Endo S, Nagai N, Yamamoto N, Funakoshi-Tago M, Donaldson PJ. Piezo1 channel causes lens sclerosis via transglutaminase 2 activation. Exp Eye Res. 2023 Dec;237:109719. doi: 10.1016/j.exer.2023.109719. Epub 2023 Nov 10.
PubMed 37951336Ortiz-Prado E, Henriquez-Trujillo AR, Rivera-Olivero IA, Lozada T, Garcia-Bereguiain MA; UDLA-COVID-19 team. High prevalence of SARS-CoV-2 infection among food delivery riders. A case study from Quito, Ecuador. Sci Total Environ. 2021 May 20;770:145225. doi: 10.1016/j.scitotenv.2021.145225. Epub 2021 Jan 17.
PubMed 33513511Galeotti C. [Mevalonate kinase deficiency]. Rev Prat. 2023 Oct;73(8):850-854. French.
PubMed 38354005
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catch up Growth Of Children After Closure Of Hemodinamically Significant Large VSD In Assuit University Children Hospital
- ClinicalTrials.gov ID
- NCT07515248
- Acronym / sponsor ID
- Catch up Growth Of Children
- Conditions
- Growth Alteration
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 7 Apr 2026 (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 primary objective of this study is to evaluate the patterns of catch-up growth in children following the closure of large VSDs.
- Specific Objectives:
- To measure anthropometric changes (Weight, Height/Length, and BMI) pre- and post-closure.
- To determine the time interval required to reach normal growth percentiles for age and sex.
- To identify predictors of poor growth recovery (e.g., age at intervention, baseline nutritional status, or residual shunts).
Detailed description
Ventricular septal defect (VSD) is the most common congenital heart disease, representing 30% to 50% of cardiac malformations at birth. It can lead to pulmonary hypertension and congestive heart failure. A hallmark clinical manifestation in these children is Failure to Thrive (FTT). The growth failure is multifactorial, resulting from increased metabolic demands (tachycardia and increased respiratory effort), inadequate caloric intake due to fatigue during feeding, chronic tissue hypoxia, and frequent lower respiratory tract infections.
Surgical closure eliminates the left-to-right shunt; restoring hemodynamic stability, reducing energy demands, improving feeding tolerance, and providing a substrate for growth recovery. Surgical correction in the first months of life is the current option for most large VSDs, as it provides complete resolution of the cardiac anomaly, with earlier control of heart failure, allowing for earlier cardiovascular drug weaning.
Although low weight at the time of repair is a known risk factor for morbidity and mortality, early surgery leads to a more favorable growth pattern. In fact, growth normalization of infants with VSD and normal birth weight who underwent primary surgical closure before the first year of life has been documented. Some reports emphasize the importance of early surgical repair for the best growth patterns in these infants. These benefits have also been observed in low birth weight infants, although with more limited growth acceleration, probably due to an early intrauterine insult. Early surgery also provides a shorter period of time at risk of heart failure complications, including respiratory infections, need for medication, and hospitalization. However, in some centers, surgery is delayed until a higher weight is achieved to reduce operative risks. The phenomenon of catch-up growth-an acceleration of growth following removal of the growth-limiting condition-is well-described in pediatric surgical literature but varies in magnitude and timing after VSD closure.
The study aims at establishing the pattern of catch-up growth in infants who have undergone surgical repair of VSD before 1 year of age and comparing it with the reference population. The research also evaluates the influence of the severity of preoperative growth failure on the postoperative growth pattern in term and preterm infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The population includes: Age group: Infants and young children aged from 1 month up to 2 years. Clinical Status: Patients presenting with symptoms of congestive heart failure and Failure to Thrive (FTT) due to the left-to-right shunt. Surgical Status: Patients who are candidates for and undergo successful surgical or interventional closure of the defect. Nutritional Status: Children exhibiting pre-operative growth retardation (low weight-for-age or height-for-age Z-scores) specifically related to their cardiac condition.
Key inclusion criteria (5 listed)
- Children diagnosed with isolated large VSD meeting the following criteria:
- Age from 1 month to 2 years old
- Symptomatic patient with hemodynamically significant VSD by echocardiography who is candidate for closure.
- Patients with pre-operative growth retardation
- Patients undergoing successful closure
Key exclusion criteria (4 listed)
- Associated complex heart lesions or cyanotic CHD (e.g., Tetralogy of Fallot).
- Genetic syndromes affecting growth (e.g., Down syndrome , Turner syndrome)
- Major extra-cardiac malformations or chronic systemic diseases (e.g., Renal failure,liver disease, metabolic disorder, Celiac disease).
- Preoperative malnutrition unrelated to cardiac disease (e.g., malabsorption syndromes
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
Change in Weight-for-Age Z-score (WAZ)
Time frame: Baseline, 6, 12, and 18 months post-closure.
Assessment of catch-up growth by measuring the change in Weight-for-Age Z-scores.
Change in Height-for-Age Z-score (HAZ)
Time frame: Baseline, 6, 12, and 18 months post-closure.
Assessment of catch-up growth by measuring the change in Height-for-Age Z-scores
Change in Weight-for-Height Z-score (WHZ
Time frame: Baseline, 6, 12, and 18 months post-closure
Assessment of catch-up growth by measuring the change in Weight-for-Height Z-scores.
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 7 Apr 2026.
- Results publication: PubMed 37951336Doki Y, Nakazawa Y, Sukegawa M, Petrova RS, Ishida Y, Endo S, Nagai N, Yamamoto N, Funakoshi-Tago M, Donaldson PJ. Piezo1 channel causes lens sclerosis via transglutaminase 2 activation. Exp Eye Res. 2023 Dec;237:109719. doi: 10.1016/j.exer.2023.109719. Epub 2023 Nov 10.
- Results publication: PubMed 33513511Ortiz-Prado E, Henriquez-Trujillo AR, Rivera-Olivero IA, Lozada T, Garcia-Bereguiain MA; UDLA-COVID-19 team. High prevalence of SARS-CoV-2 infection among food delivery riders. A case study from Quito, Ecuador. Sci Total Environ. 2021 May 20;770:145225. doi: 10.1016/j.scitotenv.2021.145225. Epub 2021 Jan 17.
- Results publication: PubMed 38354005Galeotti C. [Mevalonate kinase deficiency]. Rev Prat. 2023 Oct;73(8):850-854. French.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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?
An observational study of Growth Alteration, run by Assiut University at 1 site in Egypt.
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: opening soon, as of the sponsor's last update on 7 Apr 2026. 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 Egypt. 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 Faten S Nashed, Master Degree in Pediatrics (+201150156184, fatensamirmalak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight-for-Age Z-score (WAZ) (time frame: Baseline, 6, 12, and 18 months post-closure.). The study lists 3 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 NCT07515248, which also lists 3 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 7 Apr 2026.