Congenital Heart DiseaseNCT02475759

Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics

A study testing Nutritional perioperative prehabilitation program for two weeks and Nutritional perioperative prehabilitation program for one week in people with Congenital Heart Disease, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A randomized controlled trial. Read more about this study

Who is it for?: Any age
Conditions the study is for: Congenital Heart Disease
What is being tested?: Nutritional perioperative prehabilitation program for two weeks and Nutritional perioperative prehabilitation program for one week
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteEgypt
Study dates: 1 Nov 2017to 1 Nov 2019
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

The study included all infants with CHD, admitted to the cardiothoracic unit for either palliative or corrective surgery, and suffering from nutritional deficiencies with moderate or severe malnutrition .

Infants received long-term nutritional prehabiliatation. Those with congenital or acquired anomaly of the gastrointestinal tract; multiple congenital anomalies; chromosomal, metabolic,or endocrine diseases; any systemic illness; or fever or infection within 1 wk before the study entry were excluded

Trial locations and contacts

1 site in 1 country.

Egypt1 site

38 abbasia, next to nour mosque, Ain Shams University Hospital, Pediatrics department
Cairo, 11517

Other trials in Egypt

About this study

Official title: Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A Randomized Controlled Trial

Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A randomized controlled trial.

Read the detailed description

Nutritional Prehabilitation Program and Cardiac Surgery in Pediatrics. A randomized controlled trial to compare the outcome of malnourished congenital heart surgery patients who randomly received nutritional rehabilitation program 2 weeks and 1 week before surgical intervention.

Conditions: Congenital Heart Disease
Being tested: Nutritional perioperative prehabilitation program for two weeks, Nutritional perioperative prehabilitation program for one week
Medical subject headings: Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nutritional perioperative prehabilitation program for two weeksDietary supplement
Also called Nutritional perioperative prehabilitation program
nutritional intervention received two weeks before surgical intervention
Nutritional perioperative prehabilitation program for one weekDietary supplement
Also called Nutritional perioperative prehabilitation program
nutritional intervention received one weeks before surgical intervention

Study groups in NCT02475759
Study group	Role	What they receive
two weeks prehabilitation group	Active comparator	Nutritional perioperative prehabilitation program for two weeks in malnourished congenital heart disease children Receives: Dietary Supplement: Nutritional perioperative prehabilitation program for two weeks
one week prehabilitation group	Active comparator	Nutritional perioperative prehabilitation program for one week in malnourished congenital heart disease children Receives: Dietary Supplement: Nutritional perioperative prehabilitation program for one week

What is being measured

The primary outcome is the main question the study is designed to answer.

daily feeding characteristics
daily feeding characteristics
Measured: admission
anthropometric and laboratory measure
anthropometric and laboratory measure
Measured: admission

Secondary outcomes (3)

length of ICU stay
length of ICU stay
Measured: 3weeks
duration of mechanical ventilation and extubation timing
total days of mechanical ventilation
Measured: 3 weeks
postoperative vital stability, surgical complication,nosocomial sepsis,inotropes withdrawal
same as above
Measured: admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20171 Nov 2019

First posted19 Jun 2015 (estimated)
Study start1 Nov 2017
Primary completion1 Oct 2019
Study completion1 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
More trials run by Ain Shams 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02475759
Sponsor's protocol ID: ASU 015
Status last verified: Feb 2022
First submitted: 10 Mar 2015
Last updated: 3 Mar 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Recruiting
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
Patent Foramen Ovale, Ischemic Stroke
RecruitingObservational study
Swiss Cardiac Amyloidosis REgistry (Swiss-CARE)
Amyloid Cardiomyopathy
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction

All Congenital Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02475759
Acronym / sponsor ID: ASU 015
Conditions: Congenital Heart Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Ain Shams UniversityUniversity, hospital or other
Study start: 1 Nov 2017 (actual)
Primary completion: 1 Oct 2019 (actual)
Study completion: 1 Nov 2019 (actual)
First posted: 19 Jun 2015 (estimated)
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.

Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A randomized controlled trial.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
two weeks prehabilitation group	Active comparator	Dietary Supplement: Nutritional perioperative prehabilitation program for two weeksNutritional perioperative prehabilitation program for two weeks in malnourished congenital heart disease children
one week prehabilitation group	Active comparator	Dietary Supplement: Nutritional perioperative prehabilitation program for one weekNutritional perioperative prehabilitation program for one week in malnourished congenital heart disease children

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

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
Nutritional perioperative prehabilitation program for two weeksAlso: Nutritional perioperative prehabilitation programnutritional intervention received two weeks before surgical intervention	Dietary supplement	two weeks prehabilitation group
Nutritional perioperative prehabilitation program for one weekAlso: Nutritional perioperative prehabilitation programnutritional intervention received one weeks before surgical intervention	Dietary supplement	one week prehabilitation group

Primary outcome

daily feeding characteristics
Time frame: admission
daily feeding characteristics
anthropometric and laboratory measure
Time frame: admission
anthropometric and laboratory measure

3 secondary outcomes

length of ICU stay
Time frame: 3weeks
duration of mechanical ventilation and extubation timing
Time frame: 3 weeks
postoperative vital stability, surgical complication,nosocomial sepsis,inotropes withdrawal
Time frame: admission

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 3 Mar 2022.

Related trials for Congenital Heart Disease

RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Recruiting
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
Patent Foramen Ovale, Ischemic Stroke
RecruitingObservational study
Swiss Cardiac Amyloidosis REgistry (Swiss-CARE)
Amyloid Cardiomyopathy
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2022. 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?

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?

daily feeding characteristics (time frame: admission). The study lists 2 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 NCT02475759.

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 3 Mar 2022.