No registrations found.
ID
Source
Brief title
Health condition
premature infants, brainstem auditory evoked responses, risk factors
Sponsors and support
Intervention
Outcome measures
Primary outcome
BAER parameters.
Secondary outcome
Alteration of BAER parameters in preterm infants over time.
Background summary
Severe 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.
Study objective
Higher bilirubin levels (possibly as a results of different nutritional regiments) may alter BAER parameters and cause hearing loss.
Study design
BAER measurement will be obtained within the first 3 weeks after birth and will be repeated at 46 weeks postconceptional age.
Intervention
BAER 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.
Erasmus MC - Sophia Children’s Hospital, University Medical Center,
Department of Otorhinolaryngology,
SP-1455,
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 7036482
s.coenraad@erasmusmc.nl
Erasmus MC - Sophia Children’s Hospital, University Medical Center,
Department of Otorhinolaryngology,
SP-1455,
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 7036482
s.coenraad@erasmusmc.nl
Inclusion criteria
1. Inborn;
2. Gestational weight less than 1500g.
Exclusion criteria
1. Congenital anomalies;
2. Metabolic disease;
3. Endocrine, renal or hepatic disorder.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL1624 |
| NTR-old | NTR1720 |
| Other | METC Erasmus MC : 2008-186 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |