Growth RetardationNCT06071403
The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants
An observational study of Growth Retardation, run by Peking University at 1 site in China.
Trial summary
This study aims to estimate short-term and long-term effects of time points to cease parenteral nutrition on very preterm infants, such as growth; to estimate the role of insulin-like growth factor 1 in the growth. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Growth Retardation
- What is being tested?
- (enteral feeding volume/ total fluid volume)*100%
- How many people
- 416 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 30 Sep 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Very low birth weight infants(birth weight less than 1500 grams)
Who may be able to join
- Infants with a birth weight less than 1500 grams
- Infants admitted within 72 hours after birth
- Infants born from July 1, 2023, to June 30, 2024
- Written informed consent from parents or guardians
Who cannot join
- Infants with congenital abnormality
- Infants surviving <7 days after birth
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wei Guo
Xingtai, Hebei
Wei Guo, Doctor, 13932903599, guowei_xt@126.com
Yanguo Zhao, Master, 19831695015
About this study
Official title: The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants--A Multicenter Prospective Cohort Study
This study aims to estimate short-term and long-term effects of time points to cease parenteral nutrition on very preterm infants, such as growth; to estimate the role of insulin-like growth factor 1 in the growth.
Read the detailed description
At present, it is unclear when to cease parenteral nutrition, the effects of cessation times on preterm infants' growth, and whether insulin-like growth factor 1 (IGF-1) has a mediation effect in the procedure that nutrients regulate the growth in preterm infants.
Therefore, a prospective cohort study was designed with the aims:
- to estimate the association between the time to cease parenteral nutrition and the growth in very low birth weight;
- to investigate the relationship between nutrient volume in parenteral nutrition and growth in very low birth weight;
- to analyze the IGF-1 mediation effect between nutrient volume and growth regulations.
- Conditions
- Growth Retardation
- Being tested
- (enteral feeding volume/ total fluid volume)*100%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(enteral feeding volume/ total fluid volume)*100%Other
(enteral feeding volume/ total fluid volume)*100%. Total fluid volume is defined as enteral feeding volume + parenteral fluid volume + other fluid volume
| Study group | Role | What they receive |
|---|---|---|
| 60-70% group | We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)*100%). Receives: Other: (enteral feeding volume/ total fluid volume)*100% | |
| 71-80% group | We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)*100%). Receives: Other: (enteral feeding volume/ total fluid volume)*100% | |
| 81-90% group | We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)*100%). Receives: Other: (enteral feeding volume/ total fluid volume)*100% |
What is being measured
The primary outcome is the main question the study is designed to answer.
short-term weight and long-term weight
weight
Measured: at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age
short-term head circumference and long-term head circumference
head circumference
Measured: at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age
short-term length and long-term length
length
Measured: at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Jul 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth RetardationStudies of the same condition, open and under way.
- More trials run by Peking 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
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Shuaijun, Peking University
- Investigators
- Shuaijun Li, doctor, Study chair, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071403
- Sponsor's protocol ID
- IRB00001052-23093
- Status last verified
- Oct 2023
- First submitted
- 25 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants--A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06071403
- Acronym / sponsor ID
- IRB00001052-23093
- Conditions
- Growth Retardation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 6 Oct 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.
This study aims to estimate short-term and long-term effects of time points to cease parenteral nutrition on very preterm infants, such as growth; to estimate the role of insulin-like growth factor 1 in the growth.
Detailed description
At present, it is unclear when to cease parenteral nutrition, the effects of cessation times on preterm infants' growth, and whether insulin-like growth factor 1 (IGF-1) has a mediation effect in the procedure that nutrients regulate the growth in preterm infants.
Therefore, a prospective cohort study was designed with the aims:
- to estimate the association between the time to cease parenteral nutrition and the growth in very low birth weight;
- to investigate the relationship between nutrient volume in parenteral nutrition and growth in very low birth weight;
- to analyze the IGF-1 mediation effect between nutrient volume and growth regulations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 60-70% group | – | Other: (enteral feeding volume/ total fluid volume)*100%We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)*100%). |
| 71-80% group | – | Other: (enteral feeding volume/ total fluid volume)*100%We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)*100%). |
| 81-90% group | – | Other: (enteral feeding volume/ total fluid volume)*100%We classified subjects into 3 groups by ((enteral feeding volume/total fluid volume)*100%). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Very low birth weight infants(birth weight less than 1500 grams)
Key inclusion criteria (4 listed)
- Infants with a birth weight less than 1500 grams
- Infants admitted within 72 hours after birth
- Infants born from July 1, 2023, to June 30, 2024
- Written informed consent from parents or guardians
Key exclusion criteria (2 listed)
- Infants with congenital abnormality
- Infants surviving <7 days after birth
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 |
|---|---|---|
| (enteral feeding volume/ total fluid volume)*100%(enteral feeding volume/ total fluid volume)*100%. Total fluid volume is defined as enteral feeding volume + parenteral fluid volume + other fluid volume | Other | 60-70% group, 71-80% group, 81-90% group |
Primary outcome
short-term weight and long-term weight
Time frame: at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age
weight
short-term head circumference and long-term head circumference
Time frame: at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age
head circumference
short-term length and long-term length
Time frame: at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age
length
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
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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.
Shuaijun Li, doctor study chair
Peking University
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 Retardation, run by Peking University at 1 site in China.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Oct 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuaijun Li, doctor (18811331226, 18811331226@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short-term weight and long-term weight (time frame: at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age). 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?
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 6 Oct 2023.