PreTerm BirthNCT02970994
Linear Growth and Neurobehavioural Outcome in PT Neonates (<34 Wks) at 37 and 40 Wks of CGA
An observational study of PreTerm Birth, run by Lady Hardinge Medical College.
Trial summary
This study will evaluate the association of linear growth on neurobehavioural outcome in preterm neonates at 37 and 40 weeks of (CGA) corrected gestational age. Read more about this study
- Who is it for?
- Ages 1 day to 40 weeks
- Conditions the study is for
- PreTerm Birth
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 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 day to 40 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Haemodynamicaly stable preterm neonates <34 weeks with in 48 hours of admission
Who may be able to join
- Preterm infants ( Haemodynamicaly stable preterm neonates <34 weeks with in 48 hours of admission )
- Parental Consent
Who cannot join
- Major congenital malformation
- Haemodynamic instability
- Birth asphyxia(Apgar score of less than 7 at 1 minute of age)
- Multiple gestation.
- IVH
- Meningitis
- Hypoglycemia at admission
About this study
Official title: Linear Growth and Neurobehavioural Outcome in Preterm Neonates (<34 Weeks) at 37 Weeks and 40 Weeks of Corrected Gestational Age : a Prospective Observational Study
This study will evaluate the association of linear growth on neurobehavioural outcome in preterm neonates at 37 and 40 weeks of (CGA) corrected gestational age.
Read the detailed description
Growth of the preterm infant has historically been defined as weight gain over time. As weight gain and nutrition have been more extensively studied and their relationships with neurodevelopmental outcomes have been established, other growth parameters and their relationships to outcome need to be assessed.
Large multicenteric studies have demonstrated that poor postnatal weight gain has a negative effect on neurodevelopment . However, the neurodevelopmental consequences of linear stunting in this population were not assessed .Understanding this relationship is important because organ growth and differentiation are more closely linked to lean body mass and thus linear growth than to weight gain or fat mass alone. Moreover, weight gain and linear growth are not always tightly linked and may be influenced by both nutritional and non nutritional factors.
Linear growth represents lean body mass and protein accretion and also indexes organ growth and development, including the brain. American Academy of Pediatrics (AAP) recommends that preterm infants should grow similar to the fetus,but this guideline has been mostly applied to weight gain. As already described, the ideal weight gain to optimize neurodevelopmental outcomes has been studied extensively. However, ideal linear growth has yet to be defined. Intrauterine linear-growth velocity is approximately 1 cm/wk,and therefore is the goal that most neonatologists currently follow.Given the increasing evidence that linear-growth suppression is associated with poorer cognitive outcomes,length may now be an important anthropometric biomarker for later neurodevelopment. Research is needed to determine optimal goals of linear growth for preterm infants so as to optimize later growth and neurodevelopmental outcomes.
Recently the role of neurobehaviour has evaluated as early as at 37-40 weeks of CGA and is being predicted as an useful adjunct to the 12-18 month full neurodevelopmental assessment .Neurobehavioural assessment by tools like NAPI have been shown to correlate with BSID score at 18 months of corrected gestational age in preterm neonates.This has tremendous implications in terms of initiating an early rehabilitation /stimulation program for these neonates..
There is insufficient data on Correlation of linear growth and neurological outcome in preterm VLBW babies in India.With majority of VLBW neonates in India being SGA this assumes critical significance as growth faltering is reported to continue as late as 24 months postnatally.The linkage of linear growth faltering and poor neurodevelopmental outcome needs to be detected early in the India population and corrective strategies need to be instituted
- Conditions
- PreTerm Birth
- Keywords
- Linear growth and neurodevelopment outcome, < 34 weeks
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm neonates <34 wks | Haemodynamicaly stable preterm neonates <34 weeks with in 48 hours of admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of linear growth on neurobehavioural outcome in preterm neonates
All preterm neonates born in LHMC who meet the inclusion criteria will be included in the study with in 48 hours of admission .Demographic data, maternal history, labour details and neonatal details will be recorded in the proforma. Length will be measured using a flexible tape measuring tape and a standard infant length board to the nearest 0.1 cm . Length will be measured at time of enrolment,at time of discharge,at 37 weeks and 40 weeks of corrected gestational age.Standardized Z-scores will be calculated for the length and using reference data which included Fenton curves at birth and hospital discharge. Neonates will be evaluated by NAPI score at 37 weeks and 40 weeks of corrected gestational age for neurobehavioural assessment.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreTerm BirthStudies 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
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Hardinge Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, DR. VIKRAM DATTA, Lady Hardinge Medical College
- Investigators
- Vikram Datta, MD,DNB, Principal investigator, Lady Hardinge Medical College,New Delhi,Delhi,INDIA,110001.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970994
- Sponsor's protocol ID
- LadyHardinge MC
- Status last verified
- Mar 2017
- First submitted
- 12 Nov 2016
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Pfister KM, Ramel SE. Linear growth and neurodevelopmental outcomes. Clin Perinatol. 2014 Jun;41(2):309-21. doi: 10.1016/j.clp.2014.02.004. Epub 2014 Apr 14.
PubMed 24873834
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linear Growth and Neurobehavioural Outcome in Preterm Neonates (<34 Weeks) at 37 Weeks and 40 Weeks of Corrected Gestational Age : a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02970994
- Acronym / sponsor ID
- LadyHardinge MC
- Conditions
- PreTerm Birth
- Keywords
- Linear growth and neurodevelopment outcome, < 34 weeks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Nov 2016 (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.
This study will evaluate the association of linear growth on neurobehavioural outcome in preterm neonates at 37 and 40 weeks of (CGA) corrected gestational age.
Detailed description
Growth of the preterm infant has historically been defined as weight gain over time. As weight gain and nutrition have been more extensively studied and their relationships with neurodevelopmental outcomes have been established, other growth parameters and their relationships to outcome need to be assessed.
Large multicenteric studies have demonstrated that poor postnatal weight gain has a negative effect on neurodevelopment . However, the neurodevelopmental consequences of linear stunting in this population were not assessed .Understanding this relationship is important because organ growth and differentiation are more closely linked to lean body mass and thus linear growth than to weight gain or fat mass alone. Moreover, weight gain and linear growth are not always tightly linked and may be influenced by both nutritional and non nutritional factors.
Linear growth represents lean body mass and protein accretion and also indexes organ growth and development, including the brain. American Academy of Pediatrics (AAP) recommends that preterm infants should grow similar to the fetus,but this guideline has been mostly applied to weight gain. As already described, the ideal weight gain to optimize neurodevelopmental outcomes has been studied extensively. However, ideal linear growth has yet to be defined. Intrauterine linear-growth velocity is approximately 1 cm/wk,and therefore is the goal that most neonatologists currently follow.Given the increasing evidence that linear-growth suppression is associated with poorer cognitive outcomes,length may now be an important anthropometric biomarker for later neurodevelopment. Research is needed to determine optimal goals of linear growth for preterm infants so as to optimize later growth and neurodevelopmental outcomes.
Recently the role of neurobehaviour has evaluated as early as at 37-40 weeks of CGA and is being predicted as an useful adjunct to the 12-18 month full neurodevelopmental assessment .Neurobehavioural assessment by tools like NAPI have been shown to correlate with BSID score at 18 months of corrected gestational age in preterm neonates.This has tremendous implications in terms of initiating an early rehabilitation /stimulation program for these neonates..
There is insufficient data on Correlation of linear growth and neurological outcome in preterm VLBW babies in India.With majority of VLBW neonates in India being SGA this assumes critical significance as growth faltering is reported to continue as late as 24 months postnatally.The linkage of linear growth faltering and poor neurodevelopmental outcome needs to be detected early in the India population and corrective strategies need to be instituted
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm neonates <34 wks | – | –Haemodynamicaly stable preterm neonates <34 weeks with in 48 hours of admission |
Who may qualify
- Ages
- 1 day to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Haemodynamicaly stable preterm neonates <34 weeks with in 48 hours of admission
Key inclusion criteria (2 listed)
- Preterm infants ( Haemodynamicaly stable preterm neonates <34 weeks with in 48 hours of admission )
- Parental Consent
Key exclusion criteria (7 listed)
- Major congenital malformation
- Haemodynamic instability
- Birth asphyxia(Apgar score of less than 7 at 1 minute of age)
- Multiple gestation.
- IVH
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
Association of linear growth on neurobehavioural outcome in preterm neonates
Time frame: 18 months
All preterm neonates born in LHMC who meet the inclusion criteria will be included in the study with in 48 hours of admission .Demographic data, maternal history, labour details and neonatal details will be recorded in the proforma. Length will be measured using a flexible tape measuring tape and a standard infant length board to the nearest 0.1 cm . Length will be measured at time of enrolment,at time of discharge,at 37 weeks and 40 weeks of corrected gestational age.Standardized Z-scores will be calculated for the length and using reference data which included Fenton curves at birth and hospital discharge. Neonates will be evaluated by NAPI score at 37 weeks and 40 weeks of corrected gestational age for neurobehavioural assessment.
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 17 Mar 2017.
- Results publication: PubMed 24873834Pfister KM, Ramel SE. Linear growth and neurodevelopmental outcomes. Clin Perinatol. 2014 Jun;41(2):309-21. doi: 10.1016/j.clp.2014.02.004. Epub 2014 Apr 14.
- Individual participant dataSharing planned: Undecided
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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.
Vikram Datta, MD,DNB principal investigator
Lady Hardinge Medical College,New Delhi,Delhi,INDIA,110001.
Questions about this trial
What is this clinical trial studying?
An observational study of PreTerm Birth, run by Lady Hardinge Medical College.
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 7 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 17 Mar 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?
Association of linear growth on neurobehavioural outcome in preterm neonates (time frame: 18 months). 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 NCT02970994, which also lists 1 linked publication.
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 17 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.