Follow-up study of infants recruited to the randomised, placebo-controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants—study protocol for the AZTEC-FU study
Abstract Background Preterm birth, especially at less than 30 weeks’ gestation, is significantly associated with respiratory, neurodevelopmental and growth abnormalities. The AZTEC study has recruited 799 infants born at < 30 weeks’ gestation to determine if a ten-day intravenous treatment with a...
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| Format: | Article |
| Language: | English |
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BMC
2022-09-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06730-x |
| _version_ | 1811265226814783488 |
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| author | Sarah J. Kotecha Christopher W. Course Kathryn E. Jones W. John Watkins Janet Berrington David Gillespie Sailesh Kotecha |
| author_facet | Sarah J. Kotecha Christopher W. Course Kathryn E. Jones W. John Watkins Janet Berrington David Gillespie Sailesh Kotecha |
| author_sort | Sarah J. Kotecha |
| collection | DOAJ |
| description | Abstract Background Preterm birth, especially at less than 30 weeks’ gestation, is significantly associated with respiratory, neurodevelopmental and growth abnormalities. The AZTEC study has recruited 799 infants born at < 30 weeks’ gestation to determine if a ten-day intravenous treatment with azithromycin improves survival without development of chronic lung disease of prematurity (CLD) at 36 weeks’ post menstrual age (PMA) when compared to placebo. The follow-up studies will compare respiratory, neurodevelopmental and growth outcomes up to 2 years of corrected age between infants who received azithromycin and those who received placebo in the early neonatal period. Methods Survivors at 36 weeks’ PMA from the main Azithromycin Therapy for Chronic Lung Disease of Prematurity (AZTEC) study with parental consent will continue to be followed up to discharge from the neonatal unit and to 2 years of corrected age. Length of stay, rates of home oxygen, length of supplemental oxygen requirement, hospital admissions, drug usage, respiratory illness, neurodevelopmental disability and death rates will be reported. Data is being collected via parentally completed respiratory and neurodevelopmental questionnaires at 1 and 2 years of corrected age respectively. Additional information is being obtained from various sources including hospital discharge and clinical letters from general practitioners and hospitals as well as from national databases including the National Neonatal Research Database and NHS Digital. Discussion The AZTEC-FU study will assess mortality and important neonatal morbidities including respiratory, neurodevelopmental and growth outcomes. Important safety data will also be collected, including the incidence of potential consequences of early macrolide use, primarily pyloric stenosis. This study may have implications on future neonatal care. Trial registration The study was retrospectively registered on ISRCTN (ISRCTN47442783). |
| first_indexed | 2024-04-12T20:18:45Z |
| format | Article |
| id | doaj.art-f0b799bc01574cf894f86fecea4b10f1 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T20:18:45Z |
| publishDate | 2022-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-f0b799bc01574cf894f86fecea4b10f12022-12-22T03:18:03ZengBMCTrials1745-62152022-09-0123111010.1186/s13063-022-06730-xFollow-up study of infants recruited to the randomised, placebo-controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants—study protocol for the AZTEC-FU studySarah J. Kotecha0Christopher W. Course1Kathryn E. Jones2W. John Watkins3Janet Berrington4David Gillespie5Sailesh Kotecha6Department of Child Health, School of Medicine, Cardiff UniversityDepartment of Child Health, School of Medicine, Cardiff UniversityDepartment of Child Health, School of Medicine, Cardiff UniversityDepartment of Child Health, School of Medicine, Cardiff UniversityNeonatal Intensive Care Unit, Newcastle Upon Tyne Hospitals NHS Foundation TrustCentre for Trials Research, College of Biomedical and Life Sciences, Cardiff UniversityDepartment of Child Health, School of Medicine, Cardiff UniversityAbstract Background Preterm birth, especially at less than 30 weeks’ gestation, is significantly associated with respiratory, neurodevelopmental and growth abnormalities. The AZTEC study has recruited 799 infants born at < 30 weeks’ gestation to determine if a ten-day intravenous treatment with azithromycin improves survival without development of chronic lung disease of prematurity (CLD) at 36 weeks’ post menstrual age (PMA) when compared to placebo. The follow-up studies will compare respiratory, neurodevelopmental and growth outcomes up to 2 years of corrected age between infants who received azithromycin and those who received placebo in the early neonatal period. Methods Survivors at 36 weeks’ PMA from the main Azithromycin Therapy for Chronic Lung Disease of Prematurity (AZTEC) study with parental consent will continue to be followed up to discharge from the neonatal unit and to 2 years of corrected age. Length of stay, rates of home oxygen, length of supplemental oxygen requirement, hospital admissions, drug usage, respiratory illness, neurodevelopmental disability and death rates will be reported. Data is being collected via parentally completed respiratory and neurodevelopmental questionnaires at 1 and 2 years of corrected age respectively. Additional information is being obtained from various sources including hospital discharge and clinical letters from general practitioners and hospitals as well as from national databases including the National Neonatal Research Database and NHS Digital. Discussion The AZTEC-FU study will assess mortality and important neonatal morbidities including respiratory, neurodevelopmental and growth outcomes. Important safety data will also be collected, including the incidence of potential consequences of early macrolide use, primarily pyloric stenosis. This study may have implications on future neonatal care. Trial registration The study was retrospectively registered on ISRCTN (ISRCTN47442783).https://doi.org/10.1186/s13063-022-06730-xNeonatesPretermAzithromycinNeurodevelopmentChronic lung diseaseBronchopulmonary dysplasia |
| spellingShingle | Sarah J. Kotecha Christopher W. Course Kathryn E. Jones W. John Watkins Janet Berrington David Gillespie Sailesh Kotecha Follow-up study of infants recruited to the randomised, placebo-controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants—study protocol for the AZTEC-FU study Trials Neonates Preterm Azithromycin Neurodevelopment Chronic lung disease Bronchopulmonary dysplasia |
| title | Follow-up study of infants recruited to the randomised, placebo-controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants—study protocol for the AZTEC-FU study |
| title_full | Follow-up study of infants recruited to the randomised, placebo-controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants—study protocol for the AZTEC-FU study |
| title_fullStr | Follow-up study of infants recruited to the randomised, placebo-controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants—study protocol for the AZTEC-FU study |
| title_full_unstemmed | Follow-up study of infants recruited to the randomised, placebo-controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants—study protocol for the AZTEC-FU study |
| title_short | Follow-up study of infants recruited to the randomised, placebo-controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants—study protocol for the AZTEC-FU study |
| title_sort | follow up study of infants recruited to the randomised placebo controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants study protocol for the aztec fu study |
| topic | Neonates Preterm Azithromycin Neurodevelopment Chronic lung disease Bronchopulmonary dysplasia |
| url | https://doi.org/10.1186/s13063-022-06730-x |
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