Feeding DifficultyNCT03045978
The Association of Hormones and Peptides With Nutritional Consequences in Children With Feeding Difficulty.
An observational study of Feeding Difficulty, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
To study the role of ghrelin, leptin, adiponectin, neuropeptide Y (NPY), orexin A, IGF-1, IGFBP-1, IGFBP-3, and corticotrophin-releasing hormone (CRH) in the nutritional status in children with feeding difficulty, and further to evaluate their regulation with feeding difficulties (anorexia, picky eating behavior… Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Feeding Difficulty
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2015to Dec 2017
- Phase
- Observational
- 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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 1. Studied subjects: children with clinical diagnosis of feeding difficulty. 2. Methods of study: A total of 90 children aged 2-12 years old with feeding difficulty are enrolled into the study, and 30 healthy children are used as control. The enrolled subjects with feeding difficulty are assigned clinical survey for 12 weeks and laboratory studies at enrollment and at 12 weeks, and they are classified into 3 groups: (1) Group 1: 30 patients without malnutrition, (2) Group 2: 30 patients with mild malnutrition, and (3) Group 3: 30 patients with marked malnutrition.
Who may be able to join
- Patients with feeding difficulties are evaluated by the children gastroenterologist. The diagnosis of feeding difficulty is based on "IMFeD" program.
- Children aged 2-18 years old with feeding difficulty are enrolled.
Who cannot join
- pernicious anemia
- dysfunction of blood coagulation
- leukemias
- infection in skin of the blood collection sites
- edema, poor circulation or severe trauma of limb
- phlebitis or vein thrombosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Ghrelin, Leptin, Adiponectin, Neuropeptide Y, Orexin A, Insulin Like Growth Factor-1(IGF-1), IGFBP-1, IGFBP-3, Corticotrophin-releasing Hormone in Feeding and Nutritional Consequences in Children With Feeding Difficulty.
To study the role of ghrelin, leptin, adiponectin, neuropeptide Y (NPY), orexin A, IGF-1, IGFBP-1, IGFBP-3, and corticotrophin-releasing hormone (CRH) in the nutritional status in children with feeding difficulty, and further to evaluate their regulation with feeding difficulties (anorexia, picky eating behavior, feeding disorders with concurrent medical conditions).
Read the detailed description
The investigations plan to prospectively evaluate the plasma concentration of endocrine parameters in children with feeding difficulties. The studied children are arranged to do the dietary records, clinical survey and laboratory studies at the inpatient or outpatient department at clinical evaluation and follow-up. The duration of evaluation and follow-up is 3 months. The healthy children in the control group are also assigned to do the dietary records, clinical survey and laboratory studies after exclusion of feeding difficulty and malnutrition by feeding and nutritional assessment (same survey as the studied patients demonstrated in the following section "clinical survey"). The healthy children do not need the follow-up assessment at 12 weeks.
The diagnosis of feeding difficulty is based on "IMFeD" program. The categorizations of feeding difficulties in the IMFeD tool was originally developed by Dr. Chatoor and Dr. Kerzner (Clinical investigation of feeding difficulties in young children: a practical approach, Clinical Pediatrics, 2009). The 7-day dietary records and assessment of daily calories are evaluated by dietician and research assistant. Nutritional assessment includes 7-day dietary record, assessment of daily calories, body weight (BW), body height (BH), weight for age z-score, height for age z-score, BMI, BMI for age z-score, weight for height index, weight-for-height z-score, severity of malnutrition, and nutritional serum markers (hemoglobin, lymphocyte count, pre-albumin, albumin, ferritin, and zinc). Growth standards for height, weight, and BMI based on World Health Organization (WHO) population were used to obtain z-scores for each measurement, according to age and gender. The severity of malnutrition is determined by weight-for-height.
The laboratory studies will be performed at baseline and at 12 weeks. Venous blood is collected in Serum separation tubes and kept at 4 °C for 1 before being centrifuged, and the serum is stored at -80 °C. All measurements are performed in the same assay without extraction. Concentrations of serum ghrelin, leptin, adiponectin, NPY, orexin A, IGF-1, IGFBP-1, IGFBP-3 and CRH are all determined using enzyme-linked immunosorbent assay (ELISA) kits. All assays were performed according to the manufacturers' instructions.
- Conditions
- Feeding Difficulty
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of hormones and growth factors levels in laboratory data
Observe the level of ghrelin, leptin, adiponectin, Neuropeptide Y, orexin A, Insulin-like growth factor 1, insulin-like growth factor-binding protein 1, insulin-like growth factor-binding protein 3 and corticotropin-releasing hormone in the laboratory data.
Measured: Changes from baseline to week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study startSep 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding DifficultyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsun-Chin Chao, A.P., Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045978
- Sponsor's protocol ID
- 103-7090A3
- Status last verified
- Jan 2017
- First submitted
- 13 Jan 2017
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ghrelin, Leptin, Adiponectin, Neuropeptide Y, Orexin A, Insulin Like Growth Factor-1(IGF-1), IGFBP-1, IGFBP-3, Corticotrophin-releasing Hormone in Feeding and Nutritional Consequences in Children With Feeding Difficulty.
- ClinicalTrials.gov ID
- NCT03045978
- Acronym / sponsor ID
- 103-7090A3
- Conditions
- Feeding Difficulty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Feb 2017 (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.
To study the role of ghrelin, leptin, adiponectin, neuropeptide Y (NPY), orexin A, IGF-1, IGFBP-1, IGFBP-3, and corticotrophin-releasing hormone (CRH) in the nutritional status in children with feeding difficulty, and further to evaluate their regulation with feeding difficulties (anorexia, picky eating behavior, feeding disorders with concurrent medical conditions).
Detailed description
The investigations plan to prospectively evaluate the plasma concentration of endocrine parameters in children with feeding difficulties. The studied children are arranged to do the dietary records, clinical survey and laboratory studies at the inpatient or outpatient department at clinical evaluation and follow-up. The duration of evaluation and follow-up is 3 months. The healthy children in the control group are also assigned to do the dietary records, clinical survey and laboratory studies after exclusion of feeding difficulty and malnutrition by feeding and nutritional assessment (same survey as the studied patients demonstrated in the following section "clinical survey"). The healthy children do not need the follow-up assessment at 12 weeks.
The diagnosis of feeding difficulty is based on "IMFeD" program. The categorizations of feeding difficulties in the IMFeD tool was originally developed by Dr. Chatoor and Dr. Kerzner (Clinical investigation of feeding difficulties in young children: a practical approach, Clinical Pediatrics, 2009). The 7-day dietary records and assessment of daily calories are evaluated by dietician and research assistant. Nutritional assessment includes 7-day dietary record, assessment of daily calories, body weight (BW), body height (BH), weight for age z-score, height for age z-score, BMI, BMI for age z-score, weight for height index, weight-for-height z-score, severity of malnutrition, and nutritional serum markers (hemoglobin, lymphocyte count, pre-albumin, albumin, ferritin, and zinc). Growth standards for height, weight, and BMI based on World Health Organization (WHO) population were used to obtain z-scores for each measurement, according to age and gender. The severity of malnutrition is determined by weight-for-height.
The laboratory studies will be performed at baseline and at 12 weeks. Venous blood is collected in Serum separation tubes and kept at 4 °C for 1 before being centrifuged, and the serum is stored at -80 °C. All measurements are performed in the same assay without extraction. Concentrations of serum ghrelin, leptin, adiponectin, NPY, orexin A, IGF-1, IGFBP-1, IGFBP-3 and CRH are all determined using enzyme-linked immunosorbent assay (ELISA) kits. All assays were performed according to the manufacturers' instructions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 1. Studied subjects: children with clinical diagnosis of feeding difficulty. 2. Methods of study: A total of 90 children aged 2-12 years old with feeding difficulty are enrolled into the study, and 30 healthy children are used as control. The enrolled subjects with feeding difficulty are assigned clinical survey for 12 weeks and laboratory studies at enrollment and at 12 weeks, and they are classified into 3 groups: (1) Group 1: 30 patients without malnutrition, (2) Group 2: 30 patients with mild malnutrition, and (3) Group 3: 30 patients with marked malnutrition.
Key inclusion criteria (2 listed)
- Patients with feeding difficulties are evaluated by the children gastroenterologist. The diagnosis of feeding difficulty is based on "IMFeD" program.
- Children aged 2-18 years old with feeding difficulty are enrolled.
Key exclusion criteria (6 listed)
- pernicious anemia
- dysfunction of blood coagulation
- leukemias
- infection in skin of the blood collection sites
- edema, poor circulation or severe trauma of limb
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
The change of hormones and growth factors levels in laboratory data
Time frame: Changes from baseline to week 12.
Observe the level of ghrelin, leptin, adiponectin, Neuropeptide Y, orexin A, Insulin-like growth factor 1, insulin-like growth factor-binding protein 1, insulin-like growth factor-binding protein 3 and corticotropin-releasing hormone in the laboratory data.
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 2 Aug 2018.
- 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.
Hsun-Chin Chao, A.P. study chair
Chang Gung Memorial Hospital
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 Feeding Difficulty, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 6 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 2 Aug 2018. 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 Taiwan. 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?
The change of hormones and growth factors levels in laboratory data (time frame: Changes from baseline to week 12.). 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 2 Aug 2018.