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

Latent Iron Deficiency at Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02503397
• Other study ID #: EC/06/10/145
• Status: Completed
• Phase: N/A
• First received: July 12, 2015
• Last updated: July 17, 2015
• Start date: July 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2015
• Source: Sir Ganga Ram Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Latent Iron Deficiency at Birth

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sir Ganga Ram Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Auditory neural maturation	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	No