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Latent Iron Deficiency at Birth Influences Auditory Neural Maturation in Late Preterm and Term Infants

NCT02503397 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2015-07-21

No results posted yet for this study

Summary

This study evaluates auditory neural maturation by auditory brainstem evoked response in late preterm and term infants with in utero iron deficiency compared with neonates with normal in utero iron status.

Conditions

  • Latent Iron Deficiency at Birth

Interventions

DEVICE

Auditory brainstem evoked response (ABR)

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

Sponsors & Collaborators

  • Sir Ganga Ram Hospital

    lead OTHER

Eligibility

Min Age
1 Day
Max Age
3 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-03-31
Completion
2012-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02503397 on ClinicalTrials.gov