Diastolic DysfunctionDiFuSENCT06200519
Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography
An observational study of Diastolic Dysfunction and Neonatal Encephalopathy, run by University College Cork at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 hoursHealthy volunteers can take part
- Conditions the study is for
- Diastolic Dysfunction, Neonatal Encephalopathy, Small for Gestational Age at Delivery
- How many people
- 216 participants
- Where
- 1 siteIreland
- Study dates
- 12 Feb 2024to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 hours
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Birth at 35 weeks gestation or above
- Informed consent obtained
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
- 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)
Read the 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.
- 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
- Medical subject headings
- Transient Tachypnea of the Newborn, Down Syndrome, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 - 9 months of life, 12 - 18 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start12 Feb 2024
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diastolic DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Eugene Dempsey, University College Cork
- Investigators
- Eugene Dempsey, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200519
- Sponsor's protocol ID
- DiFuSE
- Acronym
- DiFuSE
- Status last verified
- Mar 2026
- First submitted
- 21 Dec 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27287615Kozak-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.
PubMed 10690711Khot 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.
PubMed 37153277Tao 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.
PubMed 30713044Verma 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.
PubMed 35616853Sirc 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.
PubMed 25163391Vrancken 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.
PubMed 29675404Stapleton 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.
PubMed 40829821
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06200519
- Acronym / sponsor ID
- DiFuSE / DiFuSE
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 18 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Birth at 35 weeks gestation or above
- Informed consent obtained
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reference values for diastolic function parameters in neonates
Time frame: Day 1 and Day 2 of life
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.
Persistence of diastolic function changes into infancy
Time frame: 6 - 9 months of life, 12 - 18 months of life
Assess whether the diastolic function changes noted in the first few days persist over time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 27287615Breatnach 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.
- Background: PubMed 10690711Kozak-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.
- Background: PubMed 37153277Khot 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.
- Background: PubMed 30713044Tao 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.
- Background: PubMed 35616853Verma 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.
- Background: PubMed 25163391Sirc 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.
- Background: PubMed 29675404Vrancken 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.
- Derived from this study: PubMed 40829821Stapleton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Dempsey principal investigator
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diastolic Dysfunction and Neonatal Encephalopathy, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reference values for diastolic function parameters in neonates (time frame: Day 1 and Day 2 of life). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06200519, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.