Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography

Gestational Diabetes Clinical Trial

— DiFuSE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06200519
• Other study ID #: DiFuSE
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: July 2026

Study information

• Verified date: January 2024
• Source: University College Cork
• Contact: Eugene Dempsey
• Phone: +353214920525
• Email: g.dempsey[@]ucc.ie
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: July 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Hours to 18 Hours

Eligibility

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)

Related Conditions & MeSH terms

• Brain Diseases
• Diabetes, Gestational
• Diastolic Dysfunction
• Down Syndrome
• Gestational Diabetes
• Neonatal Encephalopathy
• Small for Gestational Age at Delivery
• Tachypnea
• Transient Tachypnea of the Newborn
• Trisomy 21

Locations

Country	Name	City	State
Ireland	Cork University Maternity Hospital	Cork

Sponsors (1)

Lead Sponsor	Collaborator
University College Cork

Country where clinical trial is conducted

Ireland, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reference values for diastolic function parameters in neonates	Establish reference values for conventional and novel echocardiographic methods of assessing diastolic function in neonates and stratify them by different antenatal, intrapartum, maternal and neonatal factors to assess whether there is an association between these factors and cardiac function.	Day 1 and Day 2 of life
Primary	Persistence of diastolic function changes into infancy	Assess whether the diastolic function changes noted in the first few days persist over time.	6 - 9 months of life, 12 - 18 months of life