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Completed

NCT Number: NCT02503397

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

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.

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Key information

Age range

1 day–3 day

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auditory brainstem evoked response (ABR)

Device

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Sir Ganga Ram Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 21, 2015
Registry last updated
Jul 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.