BLUEPRINT: Predicting Long-term Outcomes of Prematurity from Early Life Events

Not Applicable

• Conditions: Prematurity; Respiratory Disease; Chronic Lung Disease of Infancy; Respiratory - Normal development and function of the respiratory system; Respiratory - Other respiratory disorders / diseases; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12624000851561
• Lead Sponsor: Murdoch Children's Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-09
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

Each infant must meet all inclusion criteria to be eligible for enrolment in the BLUEPRINT study:
1.Born between 22+0 and 31+6 weeks’ gestation.
2.Birth admission in a participating perinatal Victorian Neonatal Intensive Care Unit.
3.The infant has a parent/legal representative capable of understanding the informed consent document and providing consent on the infant’s behalf AND consent is obtained antenatally or within 72 hours from birth.
; Each infant must meet all inclusion criteria to be eligible for enrolment in the BLUEPRINT study:
1.Born between 22+0 and 31+6 weeks’ gestation.
2.Birth admission in a participating perinatal Victorian Neonatal Intensive Care Unit.
3.The infant has a parent/legal representative capable of understanding the informed consent document and providing consent on the infant’s behalf AND consent is obtained antenatally or within 72 hours from birth.

Exclusion Criteria

If any of the following exclusion criteria are met, the infant will be ineligible for enrolment in the BLUEPRINT study:
1.Infants with a known major congenital anomaly (such as oesophageal atresia and central nervous system anomalies), congenital cardiac disease, congenital diaphragmatic hernia, congenital lung abnormalities and/or pulmonary hypoplasia.
2.Pulmonary hypoplasia due to anhydramnios or oligohydramnios before 22 weeks in which the neonatal clinician anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early postnatal life.
3.Primary cause of admission unrelated to prematurity.
4.Refusal of informed consent by their legally acceptable representative.
5.The infant does not have a parent/legal representative who can provide informed consent or consent can not be obtained before 72 hours of age.
In addition, any infant identified by the treating medical team may be excluded from the study at the request of the treating clinician in consultation with the site lead investigator.
; If any of the following exclusion criteria are met, the infant will be ineligible for enrolment in the BLUEPRINT study:
1.Infants with a known major congenital anomaly (such as oesophageal atresia and central nervous system anomalies), congenital cardiac disease, congenital diaphragmatic hernia, congenital lung abnormalities and/or pulmonary hypoplasia.
2.Pulmonary hypoplasia due to anhydramnios or oligohydramnios before 22 weeks in which the neonatal clinician anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early postnatal life.
3.Primary cause of admission unrelated to prematurity.
4.Refusal of informed consent by their legally acceptable representative.
5.The infant does not have a parent/legal representative who can provide informed consent or consent can not be obtained before 72 hours of age.
In addition, any infant identified by the treating medical team may be excluded from the study at the request of the treating clinician in consultation with the site lead investigator.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The types of respiratory endotypes present in preterm infants born between 22+0 and 31+6 weeks’ gestation at 7 days after birth.<br><br>Functional respiratory endotypes are defined from clinical, plasma protein and lung imaging measures using latent class analysis followed by external validation via group-based trajectory modelling. [ At 7 days after birth ];The types of respiratory endotypes present in preterm infants born between 22+0 and 31+6 weeks’ gestation at 7 days after birth.<br><br>Functional respiratory endotypes are defined from clinical, plasma protein and lung imaging measures using latent class analysis followed by external validation via group-based trajectory modelling. [ At 7 days after birth ]