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Effect of Maternal Hemoglobin on Neurobehavioural Development of Late Preterm Neonates : A Cohort Study

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ClinicalTrials.gov Identifier: NCT02840292
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
DR. VIKRAM DATTA, Lady Hardinge Medical College

Brief 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 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.

Condition or disease
Anemia

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).

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Maternal Hemoglobin on Neurobehavioural Development of Late Preterm Neonates : A Cohort Study
Study Start Date : June 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Group/Cohort
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Comparison of NAPI Score [ Time Frame: 1 month ]
    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.



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Ages Eligible for Study:   34 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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).

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Neonates with birth asphyxia
  • Neonates with birth trauma
  • Confirmed history of substance abuse in mother.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840292


Locations
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India
Lady Hardinge Medical College
New Delhi, Delhi, India, 110001
Sponsors and Collaborators
Lady Hardinge Medical College
Investigators
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Study Chair: Dr. Vikram Datta, MD, DNB Lady Hardinge Medical College
Principal Investigator: Dr. Sanya Chandna, MBBS Lady Hardinge Medical College
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Responsible Party: DR. VIKRAM DATTA, Professor,Department of Neonatology, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT02840292    
Other Study ID Numbers: Hemoglobin and Neurobehaviour
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by DR. VIKRAM DATTA, Lady Hardinge Medical College:
Late Preterms
Neurobehavioral Assessment of Preterm Infants (NAPI)
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications