Clinical trial NCT06200519: Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography
Official title: A Longitudinal Observational Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography in Neonates Born at 35 Weeks Gestation or Above
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diastolic Dysfunction
Neonatal Encephalopathy
Small for Gestational Age at Delivery
Transient Tachypnea of the Newborn
Trisomy 21
Gestational Diabetes
Keywords: Diastolic function
Neonatal transition
Longitudinal
Tissue Doppler imaging
Speckle tracking echocardiography
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All neonates greater than or equal to 35 weeks gestational age at birth and who meet the inclusion and exclusion criteria in Table 1 below will be considered for inclusion. Informed consent will be obtained from the parent prior to inclusion.

Brief summary: The goal of this single-centre longitudinal observational study is to create reference values for diastolic function parameters in neonates born at 35 weeks' gestation or above, and to assess the influence of pre-defined antenatal, intrapartum, maternal, and neonatal factors on cardiac function.

The main question it aims to answer are:

* What are the normal reference ranges for parameters of diastolic cardiac function in neonates?
* How are these influenced by maternal, intrapartum and neonatal factors?
* Do the diastolic changes noted during the first two days of life persist into infancy?

Participants will have four echocardiographic assessments in total:

* Two during the first 48 hours of life (prior to discharge home)
* Two during infancy (as an outpatient)

Detailed description: Participants will have their first echo to assess diastolic function, using both conventional and novel echocardiographic measure, within the first 6 to 18 hours of life approximately (Day 1 scan) and this will be repeated at 30 to 42 hours of life (Day 2 scan). Both scans will involve a comprehensive structural assessment to confirm normal anatomy.

All participants will be invited to return for follow-up targeted echocardiography assessments to evaluate function at approximately 6 - 9 months (Scan 3) and at approximately 12 - 18 months of life (Scan 4). At each of these visits, their weight, height, any interim hospital admissions, serious illnesses or medical issues and medications will be documented using a structured checklist format.

Eligibility criteria: Inclusion Criteria:

* Birth at 35 weeks gestation or above
* Informed consent obtained

Exclusion Criteria:

* Any apparent congenital anomalies
* Any known chromosomal abnormalities (except Trisomy 21)
* Any known congenital structural heart disease (except patent ductus arteriosus, atrial septal defect, patent foramen ovale or ventricular septal defect)

Primary outcomes:
measure: Reference values for diastolic function parameters in neonates
timeFrame: Day 1 and Day 2 of life
measure: Persistence of diastolic function changes into infancy
timeFrame: 6 - 9 months of life, 12 - 18 months of life
Secondary outcomes:
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Maternity Hospital
Study officials:
affiliation: University College Cork
name: Eugene Dempsey
role: PRINCIPAL_INVESTIGATOR
References:
citation: Breatnach CR, Levy PT, James AT, Franklin O, El-Khuffash A. Novel Echocardiography Methods in the Functional Assessment of the Newborn Heart. Neonatology. 2016;110(4):248-260. doi: 10.1159/000445779. Epub 2016 Jun 10.
citation: Kozak-Barany A, Jokinen E, Rantonen T, Saraste M, Tuominen J, Jalonen J, Valimaki I. Efficiency of left ventricular diastolic function increases in healthy full-term infants during the first months of life. A prospective follow-up study. Early Hum Dev. 2000 Jan;57(1):49-59. doi: 10.1016/s0378-3782(99)00057-2.
citation: Khot N, Joshi S, Malwade S, Chavan S, Mane SV, Agarkhedkar S, Arora A. A Comprehensive Echocardiographic Assessment of Neonatal Right Ventricular Function in Neonatal Intensive Care Unit Babies. Cureus. 2023 Apr 5;15(4):e37166. doi: 10.7759/cureus.37166. eCollection 2023 Apr.
citation: Tao K, Hara Y, Ishihara Y, Ohshima Y. Cesarean section predominantly affects right ventricular diastolic function during the early transitional period. Pediatr Neonatol. 2019 Oct;60(5):523-529. doi: 10.1016/j.pedneo.2019.01.004. Epub 2019 Jan 19.
citation: Verma A, Suryawanshi P, Chetan C, Oka G, Singh Y, Kallimath A, Singh P, Garegrat R. A detailed echocardiographic evaluation of ventricular functions in stable full term small for gestational age babies. J Ultrasound. 2023 Mar;26(1):117-127. doi: 10.1007/s40477-022-00691-2. Epub 2022 May 26.
citation: Sirc J, Dempsey EM, Miletin J. Diastolic ventricular function improves during the first 48-hours-of-life in infants weighting <1250 g. Acta Paediatr. 2015 Jan;104(1):e1-6. doi: 10.1111/apa.12788. Epub 2014 Oct 2.
citation: Vrancken SL, van Heijst AF, de Boode WP. Neonatal Hemodynamics: From Developmental Physiology to Comprehensive Monitoring. Front Pediatr. 2018 Apr 5;6:87. doi: 10.3389/fped.2018.00087. eCollection 2018.