Latent Iron Deficiency at BirthNCT02503397
Latent Iron Deficiency at Birth Influences Auditory Neural Maturation in Late Preterm and Term Infants
An observational study of Latent Iron Deficiency at Birth, run by Sir Ganga Ram Hospital.
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. Read more about this study
- Who is it for?
- Ages 1 day to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Latent Iron Deficiency at Birth
- What is being tested?
- Auditory brainstem evoked response (ABR)
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: All neonates born between 34 - 42 weeks of gestation at Sir Ganga Ram Hospital during study period would be evaluated for enrolment in the study till 30 neonates each enrolled in the three groups: appropiate for gestational age, small for gestational age, infants of diabetic mother.
Who may be able to join
- Neonates born between 34 - 42 weeks of gestation at Sir Ganga Ram Hospital, New Delhi
Who cannot join
- craniofacial anomalies
- chromosomal disorders,
- hemolytic disease (coomb's positive),
- multiple gestation,
- history of third trimester maternal infections,
- clinical chorioamnionitis,
Show all 11Show fewer
- 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
About this study
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.
Read the 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
- Being tested
- Auditory brainstem evoked response (ABR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Latent iron deficiency | Infants with cord serum ferritin levels ≤ 75 ng/mL Receives: Device: Auditory brainstem evoked response (ABR) | |
| Normal iron status | Infants with cord serum ferritin levels > 75 ng/mL. Receives: Device: Auditory brainstem evoked response (ABR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startJul 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Latent Iron Deficiency at BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Ganga Ram Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vivek Choudhury, Sir Ganga Ram Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503397
- Sponsor's protocol ID
- EC/06/10/145
- Status last verified
- Jul 2015
- First submitted
- 12 Jul 2015
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26310540
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latent Iron Deficiency at Birth Influences Auditory Neural Maturation in Late Preterm and Term Infants
- ClinicalTrials.gov ID
- NCT02503397
- Acronym / sponsor ID
- EC/06/10/145
- Conditions
- Latent Iron Deficiency at Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sir Ganga Ram HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Latent iron deficiency | – | Device: Auditory brainstem evoked response (ABR)Infants with cord serum ferritin levels ≤ 75 ng/mL |
| Normal iron status | – | Device: Auditory brainstem evoked response (ABR)Infants with cord serum ferritin levels > 75 ng/mL. |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All neonates born between 34 - 42 weeks of gestation at Sir Ganga Ram Hospital during study period would be evaluated for enrolment in the study till 30 neonates each enrolled in the three groups: appropiate for gestational age, small for gestational age, infants of diabetic mother.
Key inclusion criteria (1 listed)
- Neonates born between 34 - 42 weeks of gestation at Sir Ganga Ram Hospital, New Delhi
Key exclusion criteria (11 listed)
- craniofacial anomalies
- chromosomal disorders,
- hemolytic disease (coomb's positive),
- multiple gestation,
- history of third trimester maternal infections,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Latent iron deficiency, Normal iron status |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
- Derived from this study: PubMed 26310540Choudhury 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Latent Iron Deficiency at Birth, run by Sir Ganga Ram Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory neural maturation (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02503397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2015.