Follow up at 1 and 2 years of corrected age for participants in the AZTEC study (Azithromycin Therapy for Chronic Lung Disease of Prematurity)

AZTEC (Azithromycin Therapy for Chronic Lung Disease of Prematurity) follow up studies: AZTEC@1 and AZTEC@2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN47442783

Enrollment

500

Registered

2022-04-12

Start date

2020-12-08

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity Pregnancy and Childbirth

Interventions

In the main AZTEC study (ISRCTN11650227) infants born at <30 weeks’ gestation, within 72 h of birth, were treated intravenously for 10 days with 20 mg/kg azithromycin for 3 days, followed by a further

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participation in the AZTEC trial 2. Survival at 36 weeks PCA 3. Consent provided by the parents/guardians to be contacted for follow-up at 1 and 2 years of corrected age

Exclusion criteria

Exclusion criteria: 1. Withdrawal from AZTEC 2. Parents/guardians did not provide consent to follow up at one and two years corrected age 3. Death prior to 36 weeks’ PCA 4. Survival not confirmed

Design outcomes

Primary

Measure	Time frame
1. Respiratory outcomes measured using parent-reported wheezing at 1 year of corrected age 2. Survival (from birth) without combined moderate/severe neurodevelopmental disability measured using the Bayley Scales of Infant Development/PARCA-R questionnaire at 2 years of corrected age	—

Secondary

Measure	Time frame
1. Mortality measured using the total number of deaths occurring during the following periods: 1.1. From birth to one- and two-year corrected age 1.2. From birth to 36 weeks’ post-conceptual age (PCA) 1.3. 36 weeks to never discharged 1.4. After discharge. 2. Length of the initial neonatal stay in hospital measured using hospital records at 1 year corrected age 3. Number of children discharged home on domiciliary ambulatory oxygen measured using hospital records at 1 year corrected age 4. Length of oxygen supplementation (including at home) measured using hospital records at 1 year corrected age 5. Respiratory outcomes from discharge to two years of corrected age measured using parent-reported wheeze at 2 years of corrected age 6. Number of respiratory hospital admissions up to one year and two years of corrected age measured using hospital records at 1 and 2 years of corrected age 7. Number of prescribed respiratory drugs measured using hospital records at 1 and 2 years corrected age 8. Survival (from birth) without parent-reported wheeze measured from parent-report at 1 and 2 years of corrected age 9. Moderate/severe neurodevelopmental disability measured using PARCA-R or by using clinical data if PARCA-R scores are missing at 2 years of corrected age. Moderate/severe neurodevelopmental disability is defined, as any of the following: 9.1. Moderate or severe visual impairment (reduced vision uncorrected with aids, blindness in one eye with good vision in the contralateral eye, or blindness or light perception only) 9.2. Moderate or severe hearing impairment (hearing loss corrected with aids, some hearing loss uncorrected by aids, or deafness) 9.3. Moderate or severe gross motor impairment (inability to walk or sit independently) 9.4. Moderate or severe cognitive impairment will be defined using PARCA-R or by using clinical data if PARCA-R scores are missing. Total PARCA-R scores of less than 44 (range, 0 to 158, with lower scores indicating greater impairment)	—

Measure

Time frame

1. Mortality measured using the total number of deaths occurring during the following periods: 1.1. From birth to one- and two-year corrected age 1.2. From birth to 36 weeks’ post-conceptual age (PCA) 1.3. 36 weeks to never discharged 1.4. After discharge. 2. Length of the initial neonatal stay in hospital measured using hospital records at 1 year corrected age 3. Number of children discharged home on domiciliary ambulatory oxygen measured using hospital records at 1 year corrected age 4. Length of oxygen supplementation (including at home) measured using hospital records at 1 year corrected age 5. Respiratory outcomes from discharge to two years of corrected age measured using parent-reported wheeze at 2 years of corrected age 6. Number of respiratory hospital admissions up to one year and two years of corrected age measured using hospital records at 1 and 2 years of corrected age 7. Number of prescribed respiratory drugs measured using hospital records at 1 and 2 years corrected age 8. Survival (from birth) without parent-reported wheeze measured from parent-report at 1 and 2 years of corrected age 9. Moderate/severe neurodevelopmental disability measured using PARCA-R or by using clinical data if PARCA-R scores are missing at 2 years of corrected age. Moderate/severe neurodevelopmental disability is defined, as any of the following: 9.1. Moderate or severe visual impairment (reduced vision uncorrected with aids, blindness in one eye with good vision in the contralateral eye, or blindness or light perception only) 9.2. Moderate or severe hearing impairment (hearing loss corrected with aids, some hearing loss uncorrected by aids, or deafness) 9.3. Moderate or severe gross motor impairment (inability to walk or sit independently) 9.4. Moderate or severe cognitive impairment will be defined using PARCA-R or by using clinical data if PARCA-R scores are missing. Total PARCA-R scores of less than 44 (range, 0 to 158, with lower scores indicating greater impairment)

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Countries

England, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026