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

NCT ID: NCT02503397

Last Updated: 2015-07-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-03-31

Brief 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.

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.

Conditions

Latent Iron Deficiency at Birth

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Latent iron deficiency

Infants with cord serum ferritin levels ≤ 75 ng/mL

Auditory brainstem evoked response (ABR)

Intervention Type: 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

Normal iron status

Infants with cord serum ferritin levels \> 75 ng/mL.

Auditory brainstem evoked response (ABR)

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Neonates born between 34 - 42 weeks of gestation at Sir Ganga Ram Hospital, New Delhi

Exclusion Criteria

• 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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sir Ganga Ram Hospital

OTHER

Sponsor Role: lead

Responsible Party

Vivek Choudhury

DNB trainee in Neonatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Choudhury V, Amin SB, Agarwal A, Srivastava LM, Soni A, Saluja S. Latent iron deficiency at birth influences auditory neural maturation in late preterm and term infants. Am J Clin Nutr. 2015 Nov;102(5):1030-4. doi: 10.3945/ajcn.115.113084. Epub 2015 Aug 26.

Reference Type: DERIVED

PMID: 26310540 (View on PubMed)

Other Identifiers

EC/06/10/145

Identifier Type: -

Identifier Source: org_study_id