- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02503397
Latent Iron Deficiency at Birth Influences Auditory Neural Maturation in Late Preterm and Term Infants
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Iron is an essential nutrient for brain development. During early human development, iron is required for multiple neurodevelopmental processes. To meet the iron requirements of a developing brain, active transfer of iron occurs across the placenta during the last trimester of pregnancy and therefore most term infants have iron replete status at birth. However, maternal iron deficiency during pregnancy, a global health problem, can negatively affect the fetal iron status. In addition, prematurity, maternal diabetes mellitus, preeclampsia, maternal smoking, and intrauterine growth restriction during pregnancy have also been associated with decreased iron transfer to the fetus often leading to in utero iron deficiency.
Cord serum ferritin (SF) level at birth provides a good measurement of fetal tissue iron storage concentration and is therefore often used to evaluate in utero iron status. The absolute and interpeak latencies on auditory brainstem evoked response (ABR) are often used as surrogate outcome measures for neural maturation in the neonates. The absolute latencies for each of these ABR waves and the interpeak latencies (IPL, I-III, III-V, and I-V) are influenced by the degree of myelination, neuronal development, synaptic function, and axonal growth in the auditory nervous system. The absolute latencies and IPL decrease as the auditory neural system matures with age in neonates.
Although iron is essential for auditory neural maturation during the perinatal period, there is a paucity of data regarding the concomitant effect of in utero iron deficiency on auditory neural maturation in late preterm and term infants. The present prospective study is planned with an objective to determine the association of in utero iron deficiency as evaluated by cord ferritin with auditory neural maturation at birth in ≥ 34 weeks GA infants.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Neonates born between 34 - 42 weeks of gestation at Sir Ganga Ram Hospital, New Delhi
Exclusion Criteria: Infants with
- craniofacial anomalies
- chromosomal disorders,
- hemolytic disease (coomb's positive),
- multiple gestation,
- history of third trimester maternal infections,
- clinical chorioamnionitis,
- Apgar score < 5 at 5 minutes,
- TORCH infections (toxoplasmosis, other infections, rubella, cytomegalovirus infection and herpes simplex),
- clinical or culture proven sepsis,
- admission to the Neonatal Intensive Care Unit,
- infants on whom cord blood not collected and on whom ABR could not be performed
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Latent iron deficiency
Infants with cord serum ferritin levels ≤ 75 ng/mL
|
Bilateral monaural auditory brainstem response (ABR) test would be recorded in each subject with a Bio-logic Navigator Evoked Response System (Bio-logic Systems, USA) between 24 and 48 hours after birth by an audiologist skilled in administering ABR to newborn infants.
ABRs shall be performed using 80 dB nHL broadband click stimuli with insert earphones and with the subject lying supine in a quiet room and normal skin temperature.
The clicks would be presented at a repetition rate of 29.9/second, and three runs of 2000 repetitions to be recorded for each ear.
The 2 most replicable runs for each ear shall be averaged and used for analysis.
Absolute latencies of waves I, III, V and IPL (I-III, III-V, and I-V) shall be measured and considered outcomes
|
Normal iron status
Infants with cord serum ferritin levels > 75 ng/mL.
|
Bilateral monaural auditory brainstem response (ABR) test would be recorded in each subject with a Bio-logic Navigator Evoked Response System (Bio-logic Systems, USA) between 24 and 48 hours after birth by an audiologist skilled in administering ABR to newborn infants.
ABRs shall be performed using 80 dB nHL broadband click stimuli with insert earphones and with the subject lying supine in a quiet room and normal skin temperature.
The clicks would be presented at a repetition rate of 29.9/second, and three runs of 2000 repetitions to be recorded for each ear.
The 2 most replicable runs for each ear shall be averaged and used for analysis.
Absolute latencies of waves I, III, V and IPL (I-III, III-V, and I-V) shall be measured and considered outcomes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Auditory neural maturation
Time Frame: 3 days
|
Auditory neural maturation as assessed by auditory brainstem response at birth in≥ 34 weeks gestational age infants with normal in utero iron status compared with infants with in utero latent iron deficiency
|
3 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC/06/10/145
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Latent Iron Deficiency at Birth
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BledinaSuspendedInterest of Biofer ® Compound Used in Blédilait Follow on Milk in Infant With Latent Iron DeficiencyLatent Iron DeficiencyFrance
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Tomsk National Research Medical Center of the Russian...RecruitingChronic Heart Failure | Iron Deficiency, LatentRussian Federation
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Qianfoshan HospitalRecruitingIron Deficiency Anemia of Pregnancy | Iron Storage DiseaseChina
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Thomas Jefferson UniversityJawaharlal Nehru Medical College; Children's Investment Fund Foundation; S. Nijalingappa... and other collaboratorsActive, not recruitingIron Deficiency Anemia | Infant, Low Birth Weight | Anemia of PregnancyIndia
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Thomas Jefferson UniversityJawaharlal Nehru Medical College; S. Nijalingappa Medical College; Raichur Institute...Active, not recruitingAutism Spectrum Disorder | Iron Deficiency Anemia | Neurodevelopmental AbnormalityIndia
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University of British ColumbiaUniversity of Guelph; NCHADS - Ministry of Health of CambodiaCompletedAnemia, Iron-Deficiency | Anemia | HemoglobinopathiesCambodia
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Services Institute of Medical Sciences, PakistanUniversidad de Granada; Allama Iqbal Medical College; Fatima Jinnah Medical UniversityActive, not recruitingPregnancy Related | Iron Deficiency (Without Anemia)Pakistan
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Thomas Jefferson UniversityJawaharlal Nehru Medical CollegeActive, not recruitingIron Deficiency Anemia | Child Development | Iron Deficiency Anemia of Pregnancy | Iron Deficiency Anemia Treatment | Neurodevelopmental Disorder of Foetus | Fetal Neurodevelopmental DisorderIndia
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Pennington Biomedical Research CenterRecruitingIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia TreatmentUnited States
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King's CollegeCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)United States
Clinical Trials on Auditory brainstem evoked response (ABR)
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Instituto de Ciências Biomédicas Abel SalazarRecruitingAutism Spectrum DisorderPortugal
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Assistance Publique - Hôpitaux de ParisActive, not recruitingAuditory Processing DisordersFrance
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Affiliated Hospital of Nantong UniversityNantong Maternal and Child Health Care HospitalActive, not recruitingHearing Loss
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Hospices Civils de LyonCompletedCochlear ImplantsFrance
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US Department of Veterans AffairsCompleted
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yangjieCompletedOutcome, Fatal | Preterm Infant | Morbidity;Infant
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Assiut UniversityUnknownHearing Impaired Children
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Universitaire Ziekenhuizen KU LeuvenFund for Scientific Research, Flanders, BelgiumCompleted
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Hospices Civils de LyonCompleted