Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography
NCT ID: NCT06200519
Last Updated: 2024-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
400 participants
OBSERVATIONAL
2024-01-31
2026-07-31
Brief Summary
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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)
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Neonates born at 35 weeks gestation and above
Stratification of population for recruitment and data analysis
1. Gestational age in weeks
2. Birth weight and centile
3. Small for gestational age (birth weight \<10th centile post-natal)
4. Large for gestational age (birth weight \>90th centile post-natal)
5. Evidence of antenatal Doppler abnormalities
6. Maternal gestational diabetes mellitus or pre-existing diabetes mellitus
7. Maternal pre-eclampsia
8. Signs of maternal chorioamnionitis
9. Mode of delivery
10. Transient Tachypnea of Newborn
11. Pregnancy conceived by assisted reproductive technologies
12. Maternal medication use
13. Suspected or confirmed Trisomy 21
14. Gestational age at birth 35-36+6 gestation group
15. Feeding type
16. Mild neonatal encephalopathy
17. Moderate and severe neonatal encephalopathy receiving therapeutic hypothermia
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Informed consent obtained
Exclusion Criteria
* 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)
6 Hours
18 Hours
ALL
Yes
Sponsors
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University College Cork
OTHER
Responsible Party
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Dr. Gene Dempsey
Horgan Chair in Neonatology, Consultant Neonatologist
Principal Investigators
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Eugene Dempsey
Role: PRINCIPAL_INVESTIGATOR
University College Cork
Locations
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Cork University Maternity Hospital
Cork, , Ireland
Countries
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Central Contacts
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Facility Contacts
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Gene Dempsey
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
Stapleton I, Bussmann N, Finn D, Livingstone V, Dempsey E. Assessment of Diastolic Function during the transitional period and infancy using Serial Echocardiography in a tertiary neonatal unit (DiFuSE): a longitudinal prospective observational study protocol. BMJ Open. 2025 Aug 19;15(8):e095984. doi: 10.1136/bmjopen-2024-095984.
Other Identifiers
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DiFuSE
Identifier Type: -
Identifier Source: org_study_id
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