AnemiaNCT02840292
Effect of Maternal Hemoglobin on Neurobehavioural Development of Late Preterm Neonates : A Cohort Study
An observational study of Anemia, run by Lady Hardinge Medical College at 1 site in India.
Trial summary
The study entitled 'Effect of maternal hemoglobin on neurobehavioral development of late preterm neonates' was done with an objective to determine whether low maternal hemoglobin (<11gm/dl), in late preterm neonates(>34weeks but less than 37weeks gestational age) correlates with poor neurobehavioral outcome using the… Read more about this study
- Who is it for?
- Ages 34 to 37 weeks
- Conditions the study is for
- Anemia
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2014to Oct 2014
- 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 34 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Study population: 100 late preterms (56 cases vs. 44 controls) fulfilling the criteria were enrolled from Main Labor Room, Maternity Ward, Operation Theatre or Post Natal Wards of the Department of Obstetrics and Gynaecology, Lady Hardinge Medical College. NAPI was administerd to 63 neonates (32 cases vs 31 controls).
Who may be able to join
- Late preterm infants born to mothers <35yrs of age and born between 34weeks to 36.6weeks of gestation as calculated by last menstrual period/1st trimester ultrasound
- Clinically stable from respiratory, hemodynamic and metabolic point of view
- After receiving full, free, voluntary, informed consent from parents/family members within 24 hours of delivery.
Who cannot join
- Chorioamnionitis in pregnancy.
- Congenital malformations (antenatally diagnosed or evident on clinical examination)
- Neonates admitted to NICU
- Neonates requiring ventilator support
- Neonates with any neurological impairment (IVH etc)
- Neonates undergoing surgery
Show all 9Show fewer
- Neonates with birth asphyxia
- Neonates with birth trauma
- Confirmed history of substance abuse in mother.
Trial locations and contacts
1 site in 1 country.
India1 site
Lady Hardinge Medical College
New Delhi, National Capital Territory of Delhi, 110001
About this study
The study entitled 'Effect of maternal hemoglobin on neurobehavioral development of late preterm neonates' was done with an objective to determine whether low maternal hemoglobin (<11gm/dl), in late preterm neonates(>34weeks but less than 37weeks gestational age) correlates with poor neurobehavioral outcome using the Neurobehavioral Assessment of Preterm Infants(NAPI) tool, thereby allowing for earlier rehabilitative intervention to be undertaken to improve their long term outcomes and to generate useful data on a previously well recognised but under researched entity.
Read the detailed description
Prevalence of anemia in India is among the highest in the world. A high proportion of women in both industrialized and developing countries become anemic during pregnancy. The major concern about the adverse effects of anemia on pregnant women and their offsprings is the belief that this population is at a greater risk of perinatal mortality and morbidity. Apart from this, it is well known that anemia per se is associated with higher incidence of premature births and low birth weight babies. Infants with iron deficiency anemia have significantly lower motor and mental scores and decreased language capabilities and body balance-coordination skills. Such infants also have a decreased learning ability. Iron deficiency anemia during the developmental stage can lead to reduced myelination of the spinal cord, as well as a change in myelin composition; abnormalities in neurotransmitters' metabolism and alteration in brain energy metabolism. The Neurobehavioral Assessments of Preterm Infants (NAPI) is a research tool to monitor the developmental progress and differential maturity of preterm infants ranging between 32weeks and 37weeks (full term). This test is used to identify persistent lags in development, as a research tool to assess effects of interventions and to study individual differences and basic developmental questions. The reliability and clinical validity of this test has been thoroughly investigated and normative data has been established.
Objective - To evaluate the neurobehavioral development at 37weeks of post conceptional age in late preterm infants born to mothers with hemoglobin <11gm/dl; by a standardised scale - Neurobehavioral Assessment of Preterm Infants (NAPI).
- Conditions
- Anemia
- Keywords
- Late Preterms, Neurobehavioral Assessment of Preterm Infants (NAPI)
- Medical subject headings
- Anemia
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 |
|---|---|---|
| Cases | Late preterm neonates (>34weeks but <37weeks of gestation) with maternal hemoglobin < 11gm/dl | |
| Controls | Late preterm neonates (>34weeks but <37weeks of gestation) with maternal haemoglobin ≥ 11gm/dl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of neurobehavioral development
The two sub domains of Neurobehavioral Assessment of Preterm Infants (NAPI) i.e. Motor Development and Vigor (MDV) and Alertness and Orientations (AO) were tested to evaluate the neurobehavioral development at 37weeks of post conceptional age in late preterm neonates
Measured: 2 months
Secondary outcomes (1)
Comparison of NAPI Score
The scores of the two sub domains of Neurobehavioral Assessment of Preterm Infants (NAPI) i.e. Motor Development and Vigor (MDV) and Alertness and Orientations (AO) were compared to determine the level of maturity in the neurobehavioral development in cases and controls.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- 100 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
- Dr. Vikram Datta, MD, DNB, Study chair, Lady Hardinge Medical CollegeDr. Sanya Chandna, MBBS, Principal investigator, Lady Hardinge Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840292
- Sponsor's protocol ID
- Hemoglobin and Neurobehaviour
- Status last verified
- Jul 2016
- First submitted
- 19 Jul 2016
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maternal Hemoglobin on Neurobehavioural Development of Late Preterm Neonates : A Cohort Study
- ClinicalTrials.gov ID
- NCT02840292
- Acronym / sponsor ID
- Hemoglobin and Neurobehaviour
- Conditions
- Anemia
- Keywords
- Late Preterms, Neurobehavioral Assessment of Preterm Infants (NAPI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 21 Jul 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.
The study entitled 'Effect of maternal hemoglobin on neurobehavioral development of late preterm neonates' was done with an objective to determine whether low maternal hemoglobin (<11gm/dl), in late preterm neonates(>34weeks but less than 37weeks gestational age) correlates with poor neurobehavioral outcome using the Neurobehavioral Assessment of Preterm Infants(NAPI) tool, thereby allowing for earlier rehabilitative intervention to be undertaken to improve their long term outcomes and to generate useful data on a previously well recognised but under researched entity.
Detailed description
Prevalence of anemia in India is among the highest in the world. A high proportion of women in both industrialized and developing countries become anemic during pregnancy. The major concern about the adverse effects of anemia on pregnant women and their offsprings is the belief that this population is at a greater risk of perinatal mortality and morbidity. Apart from this, it is well known that anemia per se is associated with higher incidence of premature births and low birth weight babies. Infants with iron deficiency anemia have significantly lower motor and mental scores and decreased language capabilities and body balance-coordination skills. Such infants also have a decreased learning ability. Iron deficiency anemia during the developmental stage can lead to reduced myelination of the spinal cord, as well as a change in myelin composition; abnormalities in neurotransmitters' metabolism and alteration in brain energy metabolism. The Neurobehavioral Assessments of Preterm Infants (NAPI) is a research tool to monitor the developmental progress and differential maturity of preterm infants ranging between 32weeks and 37weeks (full term). This test is used to identify persistent lags in development, as a research tool to assess effects of interventions and to study individual differences and basic developmental questions. The reliability and clinical validity of this test has been thoroughly investigated and normative data has been established.
Objective - To evaluate the neurobehavioral development at 37weeks of post conceptional age in late preterm infants born to mothers with hemoglobin <11gm/dl; by a standardised scale - Neurobehavioral Assessment of Preterm Infants (NAPI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Late preterm neonates (>34weeks but <37weeks of gestation) with maternal hemoglobin < 11gm/dl |
| Controls | – | –Late preterm neonates (>34weeks but <37weeks of gestation) with maternal haemoglobin ≥ 11gm/dl |
Who may qualify
- Ages
- 34 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 100 late preterms (56 cases vs. 44 controls) fulfilling the criteria were enrolled from Main Labor Room, Maternity Ward, Operation Theatre or Post Natal Wards of the Department of Obstetrics and Gynaecology, Lady Hardinge Medical College. NAPI was administerd to 63 neonates (32 cases vs 31 controls).
Key inclusion criteria (3 listed)
- Late preterm infants born to mothers <35yrs of age and born between 34weeks to 36.6weeks of gestation as calculated by last menstrual period/1st trimester ultrasound
- Clinically stable from respiratory, hemodynamic and metabolic point of view
- After receiving full, free, voluntary, informed consent from parents/family members within 24 hours of delivery.
Key exclusion criteria (9 listed)
- Chorioamnionitis in pregnancy.
- Congenital malformations (antenatally diagnosed or evident on clinical examination)
- Neonates admitted to NICU
- Neonates requiring ventilator support
- Neonates with any neurological impairment (IVH etc)
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
Evaluation of neurobehavioral development
Time frame: 2 months
The two sub domains of Neurobehavioral Assessment of Preterm Infants (NAPI) i.e. Motor Development and Vigor (MDV) and Alertness and Orientations (AO) were tested to evaluate the neurobehavioral development at 37weeks of post conceptional age in late preterm neonates
1 secondary outcome
Comparison of NAPI Score
Time frame: 1 month
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 21 Jul 2016.
- 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.
Dr. Vikram Datta, MD, DNB study chair
Lady Hardinge Medical College
Dr. Sanya Chandna, MBBS principal investigator
Lady Hardinge Medical College
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 Anemia, run by Lady Hardinge Medical College at 1 site in India.
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 3 inclusion and 9 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 21 Jul 2016. 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 India. 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?
Evaluation of neurobehavioral development (time frame: 2 months). 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 21 Jul 2016.