An observational study in Premature Baby, Pulmonary Hypertension of Newborn and Hypoxic Ischaemic Encephalopathy (HIE), sponsored by Birmingham Women's NHS Foundation Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 0 Minutes to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Birmingham Women's NHS Foundation Trust · Observational
Among 100 studies in Premature Birth with a site in United Kingdom — 19 open to participants now, 25 under way, 1 of them phase 3. Premature Birth · United Kingdom.
Among the 100 studies in Premature Birth with a site in United Kingdom, this one is the 18th largest by planned enrollment of the 46 observational ones that give a count, is one of 3 that started in 2026, is one of 46 observational ones, reaches primary completion later than 23 of the 24 other live ones, and was the 98th registered.
2,553 studies on the registry are indexed under Premature Birth; 502 are open to participants now.
Browse Premature Birth studies →19 of the 100 studies in Premature Birth with a site in United Kingdom are open now. Recruiting first, the newest first:
King's College Hospital NHS Trust · Sites in United Kingdom
Ages 22 wk–34 wk
Imperial College Healthcare NHS Trust · Sites in United Kingdom
Ages 23 wk–30 wk
Imperial College London · Sites in United Kingdom
Ages up to 30 wk
South Tees Hospitals NHS Foundation Trust · Sites in United Kingdom
Ages 22 wk–32 wk
Queen Mary University of London · Sites in United Kingdom
Ages 18+ · Women only
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 315 Premature Birth studies recruiting now, 88 (28%) set no upper age limit and 223 (71%) stop at 75 or younger; 241 take children under 18; 105 take healthy volunteers.
This study: 0 Minutes to 8 Weeks · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
100 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 190 is above the median of 120 across 806 observational studies indexed under Premature Birth.
Median enrollment 58 across the 54 interventional studies, 150 across the 46 observational. Of the 56 that completed or were terminated, 8 (14%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 100 have an industry lead sponsor. The 10 most frequent:
Birmingham Women's NHS Foundation Trust is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Birmingham Women's NHS Foundation Trust has 1 study filed under Premature Birth — fewer than ten, so there is no comparison to draw.
10 of the studies in Premature Birth with a site in United Kingdom that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03168516Phase 3University Hospital TuebingenEffects of Closed-loop Automatic Control of FiO2 in Extremely Preterm Infants | 2026-12 |
| NCT04372953Murdoch Childrens Research InstitutePositive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial). | 2026-11-30 |
| NCT05306925University of LiverpoolAn Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse | 2026-12-31 |
| NCT06823115Indiana UniversityAssessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0 | 2027-01 |
| NCT07191678Imperial College Healthcare NHS TrustMechanisms Affecting the Gut of Preterm Infants Receiving Blood Transfusion With Different Enteral Feed Interventions | 2027-01-31 |
Add all 10 to your calendar (.ics) → With an account.
Among the 100 studies in Premature Birth with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study aims to improve how neonatologists check the heart function of newborn babies, especially those who are sick. While standard heart ultrasound scans are useful, a more advanced and sensitive technique called 2D speckle tracking echocardiography (STE) can detect subtle problems with how the heart muscle squeezes and relaxes. This may allow doctors to spot potential issues earlier.
Our research will take place at Birmingham Women's Hospital. The investigators will perform these advanced, non-invasive heart scans on several groups of babies:
The heart scan is a standard, painless procedure. Using STE does not require any extra scanning time or cause any additional discomfort to the baby; the special images are taken during the routine scan. For many of the sick babies, these scans are already part of their normal clinical care.
The main goals of this observational study are to see if STE is a feasible and reliable tool in newborns, to establish normal values for healthy babies, and to track how heart function changes in sick babies during their illness and recovery.
Ultimately, the investigators hope this research will provide doctors with a better tool to assess heart health in newborns. This could lead to earlier, more accurate detection of heart problems and help guide treatment decisions to improve outcomes for these vulnerable infants.
Inpatient status at Birmingham Women's Hospital Neonatal Unit - only babies admitted to the neonatal unit, transitional care ward or postnatal ward will be considered for screening.
Belong to one of the following target clinical groups:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
OR
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Term neonates diagnosed with Congenital Diaphragmatic Hernia (CDH)
Term neonates diagnosed with Hypoxic Ischaemic Encephalopathy (HIE) and receiving therapeutic hypothermia.
Term neonates diagnosed with Acute Pulmonary Hypertension of the Newborn (aPHN), excluding those with CDH.
Preterm neonates born at or before 32 weeks' gestation, who are later diagnosed with Chronic Lung Disease (CLD) requiring supplemental oxygen at 36 weeks corrected gestational age.
(\<36 weeks' gestation) admitted to the NICU and transitional care. Stratified into extreme preterm, moderately preterm and late preterm.
(\>36 weeks' gestation) who are well and on postnatal wards.
To assess the feasibility of acquiring adequate quality images for comprehensive Right ventricular - Speckle Tracking Echocardiography (RV-STE), Left ventricular (LV) STE, and left atrial (LA) -STE in neonates with aPHN, CDH, HIE, and BPD.
Feasibility rate of RV, LV, and LA STE.
Time frame: By completion of data collection (September 2027)
To describe the longitudinal changes in RV, LV, and LA STE parameters from acute illness through recovery/discharge in each disease cohort.
The invetigators will measure this by looking at values and longitudinal trends of: RV-Global Longitudinal Strain (GLS), RV-Free Wall Longitudinal Strain (FWLS), LV-GLS, LA reservoir strain (LASr) in healthy neonates and neonates with disease conditions (HIE, BPD, CDH, aPHN).
Time frame: By September 2027
To establish normative values of simultaneously performed RV, LV and LA strain in well term and preterm neonates
The investigators will establish normative reference RV, LV and LA strain using two-dimensional speckle-tracking echocardiography in a cohort of well term and preterm neonates. Report Strain values as means ± standard deviations and percentiles (5th-95th), stratified by gestational age, postnatal age, and birth weight categories.
Time frame: By September 2027
To evaluate the intra-observer and inter-observer reproducibility of RV, LV, and LA STE measurements
The investigators will use intra-class correlation coefficients (ICC), Bland-Altman limits of agreement, and coefficient of variation (CV) for key STE parameters.
Time frame: By September 2027
To compare STE-derived parameters with conventional echocardiographic measures of cardiac function.
Correlation and agreement between speckle tracking echocardiography (STE)-derived parameters (STE derived EF, STE derived TAPSE) and conventional echocardiographic measures of cardiac function (EF by Simpson Biplane technique, M-mode TAPSE).
Time frame: By September 2027
To compare RV, LV, and LA STE parameters between the different disease cohorts and a cohort of healthy control neonate
Comparison of right ventricular (RV), left ventricular (LV), and left atrial (LA) strain and strain rate parameters derived from speckle tracking echocardiography (STE) between neonates in different disease cohorts and a healthy control group.
Time frame: By September 2027
Plan to share: No — The REC required removal of the proposed wording allowing anonymised participant data to be shared with external researchers on request. As participants are not being consented for future research data sharing, the study has no plan to share IPD, and the ClinicalTrials.gov IPD field is therefore recorded as "No". This is an observational trial with no intervention and not a clinical trial of a device or drug.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Feb 2028, 17 months later.
Of 372 non-industry observational studies under Premature Birth, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 63. This study's planned 17 months is below that.
Counting every sponsor, half of 387 studies reached it within 35 months; a quarter within 18 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Birmingham Women's NHS Foundation Trust