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Brainstem auditory evoked response (BAER) measurement in premature infants; effect of bilirubin levels and different nutritional regiments.


- candidate number5442
- NTR NumberNTR1720
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-mrt-2009
- Secondary IDs2008-186 METC Erasmus MC
- Public TitleBrainstem auditory evoked response (BAER) measurement in premature infants; effect of bilirubin levels and different nutritional regiments.
- Scientific TitleBrainstem auditory evoked response (BAER) measurement in premature infants; effect of bilirubin levels and different nutritional regiments.
- ACRONYMBAER measurement in NICU infants
- hypothesisHigher bilirubin levels (possibly as a results of different nutritional regiments) may alter BAER parameters and cause hearing loss.
- Healt Condition(s) or Problem(s) studiedPremature infants, Brainstem response, Auditive
- Inclusion criteria1. Inborn;
2. Gestational weight less than 1500g.
- Exclusion criteria1. Congenital anomalies;
2. Metabolic disease;
3. Endocrine, renal or hepatic disorder.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2009
- planned closingdate1-okt-2010
- Target number of participants75
- InterventionsBAER recording will be conducted at 7 (+/- 2) and 14 (+/- 2) days postnatally and at 46 weeks postconceptional age.

Children will be randomly selected from the following nutritional intervention groups (NIPI-2):
Group A will receive lipids from birth onwards. Group B will receive extra amino acids in combination with lipids from birth onwards. The control group will be fed according to the standard nutrition policy (lipids from day 2 or 3 onwards). Different lipid emulsions will be compared.
- Primary outcomeBAER parameters.
- Secondary outcomeAlteration of BAER parameters in preterm infants over time.
- TimepointsBAER measurement will be obtained within the first 3 weeks after birth and will be repeated at 46 weeks postconceptional age.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. S. Coenraad
- CONTACT for SCIENTIFIC QUERIESDrs. S. Coenraad
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Sophia Children's Hospital
- PublicationsN/A
- Brief summarySevere hyperbilirubinemia is known to cause sensorineural hearing loss. An incidence of up to 87% for hearing function disorders diagnosed by abnormal BAER results has been reported18. It is reported that BAER parameters can improve after blood transfusion19-21. However in about 50% of children non reversible changes were found22. Most of these results are from studies in full term neonates. It is suggested that preterm infants are at higher risk of developing hearing disorders as a result of hyperbilirubinemia because the auditory system is affected in an earlier stage of maturation18. In this study we will investigate the effect of bilrubin levels on hearing function in preterm infants by BAER testing. We will investigate changes in auditory function by repeating BEAR testing at 46 weeks postmenstrual age.
- Main changes (audit trail)
- RECORD11-mrt-2009 - 14-sep-2009


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