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

NCT06200519 | Active Not Recruiting

• 1 other identifier: DiFuSE
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

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)

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 6 Hours - 18 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

Cork University Maternity Hospital

Cork, T12 DC4A, Ireland

Location

Related Publications (8)

• 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.

  PMID: 27287615 BACKGROUND

• 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.

  PMID: 10690711 BACKGROUND

• 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.

  PMID: 37153277 BACKGROUND

• 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.

  PMID: 30713044 BACKGROUND

• 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.

  PMID: 35616853 BACKGROUND

• 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.

  PMID: 25163391 BACKGROUND

• 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.

  PMID: 29675404 BACKGROUND

• 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.

  PMID: 40829821 DERIVED

MeSH Terms

Conditions

Transient Tachypnea of the Newborn; Down Syndrome; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Eugene Dempsey

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Horgan Chair in Neonatology, Consultant Neonatologist

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 11, 2024
• Study Start: February 12, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

IE (1)