Preterm InfantNCT03104946
To Research the Relation Between Neonatal Morbidities and Poor Outcome in Preterm Infants
An observational study of Preterm Infant and Morbidity;Infant, run by yangjie.
Trial summary
From November 2014 to October 2015, a multi-centers retrospective study was conducted to collect compliance, and 8 three-level hospitals from China were included. The infants survived to a postmenstrual age of 36 week with birth weight less than 1500g and without congenital disease. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Preterm Infant, Morbidity;Infant, Outcome, Fatal
- What is being tested?
- Mental Development Index;Auditory Brainstem Response;okineticnystagmus
- How many people
- 834 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2013to 30 Nov 2016
- 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 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: From November 2014 to October 2015, a multi-centers retrospective study was conducted to collect compliance, and 8 three-level hospitals from China were included. The infants survived to a postmenstrual age of 36 week with birth weight less than 1500g and without congenital disease.
Who may be able to join
- From November 2014 to October 2015, a multi-centers retrospective study was conducted to collect compliance, and 8 three-level hospitals from China were included. The infants survived to a postmenstrual age of 36 week with birth weight less than 1500g.
Who cannot join
- The very low birth weight infants didn't have any congenital disease.
About this study
Official title: Clinical Research on the Predictive Effect of Neonatal Morbidities on the Poor Outcomes to Very Low Birth-weight and Extremely Low Birth-weight Infants
From November 2014 to October 2015, a multi-centers retrospective study was conducted to collect compliance, and 8 three-level hospitals from China were included. The infants survived to a postmenstrual age of 36 week with birth weight less than 1500g and without congenital disease. The birth weight, gestational age, morbidities and poor outcomes( death, cerebral palsy, cognitive, et al) were recorded. Data were analyzed with Chi-square test to observe the relationship between morbidities and poor outcomes. And the predictive effect on the number of the top three morbidities were analyzed by Logistic regression analysis.
- Conditions
- Preterm Infant, Morbidity;Infant, Outcome, Fatal
- Being tested
- Mental Development Index;Auditory Brainstem Response;okineticnystagmus
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Development Index;Auditory Brainstem Response;okineticnystagmusDiagnostic test
mental development index(MDI）<70:cognitive delay do not pass auditory brainstem response(ABR）：hearing impairment do not pass okineticnystagmus:visual impairment Patent Ductus Arteriosus
| Study group | Role | What they receive |
|---|---|---|
| Bronchopulmonary Dysplasia | Not described Receives: Diagnostic Test: Mental Development Index;Auditory Brainstem Response;okineticnystagmus | |
| Retinopathy | Not described Receives: Diagnostic Test: Mental Development Index;Auditory Brainstem Response;okineticnystagmus | |
| Severe Retinopathy | Not described Receives: Diagnostic Test: Mental Development Index;Auditory Brainstem Response;okineticnystagmus | |
| Neonatal Necrotizing Enterocolitis | Not described Receives: Diagnostic Test: Mental Development Index;Auditory Brainstem Response;okineticnystagmus | |
| Brain injury | Not described Receives: Diagnostic Test: Mental Development Index;Auditory Brainstem Response;okineticnystagmus | |
| sepsis | Not described Receives: Diagnostic Test: Mental Development Index;Auditory Brainstem Response;okineticnystagmus | |
| Patent Ductus Arteriosus | Not described Receives: Diagnostic Test: Mental Development Index;Auditory Brainstem Response;okineticnystagmus | |
| Respiratory Distress Syndrome | Not described Receives: Diagnostic Test: Mental Development Index;Auditory Brainstem Response;okineticnystagmus |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive delay
mental development index(MDI）<70
Measured: 1 year
hearing impairment
do not pass auditory brainstem response (ABR)
Measured: 1 year
visual impairment
do not pass okineticnystagmus
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start1 Sep 2013
- Primary completion30 Nov 2015
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 834 participants (actual)
Sponsor and investigators
- Lead sponsor
- yangjie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yangjie, Guangdong Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104946
- Sponsor's protocol ID
- Guangdong WCH
- Status last verified
- Mar 2017
- First submitted
- 28 Mar 2017
- Last updated
- 7 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schmidt B, Asztalos EV, Roberts RS, Robertson CM, Sauve RS, Whitfield MF; Trial of Indomethacin Prophylaxis in Preterms (TIPP) Investigators. Impact of bronchopulmonary dysplasia, brain injury, and severe retinopathy on the outcome of extremely low-birth-weight infants at 18 months: results from the trial of indomethacin prophylaxis in preterms. JAMA. 2003 Mar 5;289(9):1124-9. doi: 10.1001/jama.289.9.1124.
PubMed 12622582Rao YB, Yang J, Cao B, Chen DM, Gao PM, Zhong Q, Li MX, Gao JH, Chen YJ, Zhong XM, Ren ZX. [Predictive effect of neonatal morbidities on the poor outcomes at 12 months corrected age in very low birth weight premature infants]. Zhonghua Er Ke Za Zhi. 2017 Aug 2;55(8):608-612. doi: 10.3760/cma.j.issn.0578-1310.2017.08.012. Chinese.
PubMed 28822437
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on the Predictive Effect of Neonatal Morbidities on the Poor Outcomes to Very Low Birth-weight and Extremely Low Birth-weight Infants
- ClinicalTrials.gov ID
- NCT03104946
- Acronym / sponsor ID
- Guangdong WCH
- Conditions
- Preterm Infant, Morbidity;Infant, Outcome, Fatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 834 participants (actual)
- Lead sponsor
- yangjieUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 7 Apr 2017 (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.
From November 2014 to October 2015, a multi-centers retrospective study was conducted to collect compliance, and 8 three-level hospitals from China were included. The infants survived to a postmenstrual age of 36 week with birth weight less than 1500g and without congenital disease. The birth weight, gestational age, morbidities and poor outcomes( death, cerebral palsy, cognitive, et al) were recorded. Data were analyzed with Chi-square test to observe the relationship between morbidities and poor outcomes. And the predictive effect on the number of the top three morbidities were analyzed by Logistic regression analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Bronchopulmonary Dysplasia | – | Diagnostic Test: Mental Development Index;Auditory Brainstem Response;okineticnystagmus |
| Retinopathy | – | Diagnostic Test: Mental Development Index;Auditory Brainstem Response;okineticnystagmus |
| Severe Retinopathy | – | Diagnostic Test: Mental Development Index;Auditory Brainstem Response;okineticnystagmus |
| Neonatal Necrotizing Enterocolitis | – | Diagnostic Test: Mental Development Index;Auditory Brainstem Response;okineticnystagmus |
| Brain injury | – | Diagnostic Test: Mental Development Index;Auditory Brainstem Response;okineticnystagmus |
| sepsis | – | Diagnostic Test: Mental Development Index;Auditory Brainstem Response;okineticnystagmus |
| Patent Ductus Arteriosus | – | Diagnostic Test: Mental Development Index;Auditory Brainstem Response;okineticnystagmus |
| Respiratory Distress Syndrome | – | Diagnostic Test: Mental Development Index;Auditory Brainstem Response;okineticnystagmus |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- From November 2014 to October 2015, a multi-centers retrospective study was conducted to collect compliance, and 8 three-level hospitals from China were included. The infants survived to a postmenstrual age of 36 week with birth weight less than 1500g and without congenital disease.
Key inclusion criteria (1 listed)
- From November 2014 to October 2015, a multi-centers retrospective study was conducted to collect compliance, and 8 three-level hospitals from China were included. The infants survived to a postmenstrual age of 36 week with birth weight less than 1500g.
Key exclusion criteria (1 listed)
- The very low birth weight infants didn't have any congenital disease.
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 |
|---|---|---|
| Mental Development Index;Auditory Brainstem Response;okineticnystagmusmental development index(MDI）<70:cognitive delay do not pass auditory brainstem response(ABR）：hearing impairment do not pass okineticnystagmus:visual impairment Patent Ductus Arteriosus | Diagnostic test | Brain injury, Bronchopulmonary Dysplasia, Neonatal Necrotizing Enterocolitis, Patent Ductus Arteriosus, Respiratory Distress Syndrome, Retinopathy, Severe Retinopathy, sepsis |
Primary outcome
cognitive delay
Time frame: 1 year
mental development index(MDI）<70
hearing impairment
Time frame: 1 year
do not pass auditory brainstem response (ABR)
visual impairment
Time frame: 1 year
do not pass okineticnystagmus
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 7 Apr 2017.
- Background: PubMed 12622582Schmidt B, Asztalos EV, Roberts RS, Robertson CM, Sauve RS, Whitfield MF; Trial of Indomethacin Prophylaxis in Preterms (TIPP) Investigators. Impact of bronchopulmonary dysplasia, brain injury, and severe retinopathy on the outcome of extremely low-birth-weight infants at 18 months: results from the trial of indomethacin prophylaxis in preterms. JAMA. 2003 Mar 5;289(9):1124-9. doi: 10.1001/jama.289.9.1124.
- Derived from this study: PubMed 28822437Rao YB, Yang J, Cao B, Chen DM, Gao PM, Zhong Q, Li MX, Gao JH, Chen YJ, Zhong XM, Ren ZX. [Predictive effect of neonatal morbidities on the poor outcomes at 12 months corrected age in very low birth weight premature infants]. Zhonghua Er Ke Za Zhi. 2017 Aug 2;55(8):608-612. doi: 10.3760/cma.j.issn.0578-1310.2017.08.012. Chinese.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Infant and Morbidity;Infant, run by yangjie.
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 1 inclusion and 1 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 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
cognitive delay (time frame: 1 year). 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 NCT03104946, which also lists 2 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 2017.