Clinical Trials Logo

Clinical Trial Summary

Babies may be born appropriately grown for gestational age (AGA, >10th centile) or small for gestational age (SGA, <10th centile). Babies who are SGA and have evidence in utero of vascular compromise using antenatal doppler indices are classified as having fetal growth restriction (FGR). Babies with FGR are at increased risk of cardiovascular disease in adult life. Increased arterial stiffness and intima-media thickness are thought to mediate this risk in adults. It is not known how early in life these changes can be robustly detected. In addition, very little is known generally about how babies' hearts and arteries change in structure and function over the first year of life, whether affected by SGA or not. This study aims to understand if there are differences in cardiac and arterial structure and function between babies born AGA or SGA. Within the group of SGA babies, the study team will investigate whether FGR and maternal pre-eclampsia influence these measurements. The effects gestational age on these parameters will be studied within all groups: half of the babies recruited will be <32 weeks gestational age (GA), and half will be ≥32 weeks GA. Study participants will have further measurements at 3-6 months of life to assess if cardiac and arterial structure and function change in babies over the first year of life. The study team will use the Vicorder device to measure arterial stiffness, and assess the feasibility of using this device in neonates. The Vicorder will also be used to measure cardiac output. The feasibility and validity of this device for this purpose will be investigated (Vicorder is not validated for cardiac output measurement in infants). Vicorder cardiac output results will be compared to echocardiography and bioimpedence technology (using the NICaS monitor). The study team will use ultrasound for arterial structure measurements of the carotid artery and aorta.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04720690
Study type Observational
Source Imperial College Healthcare NHS Trust
Contact Jayanta Banerjee, MD (Res), FRCPCH
Phone 020 3313 7308
Email j.banerjee@imperial.ac.uk
Status Recruiting
Phase
Start date December 1, 2020
Completion date December 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03299777 - Correlation Between Changes in Liver Stiffness and Preeclampsia as Shown by Fibroscan N/A
Completed NCT03650790 - C1q/TNF-related Protein 9 (CTRP 9) Level in Preeclamptic Obese and Non-obese Pregnancies N/A
Recruiting NCT03605511 - TTP and aHUS in Complicated Pregnancies
Not yet recruiting NCT03302260 - Identifying Methods for Postpartum Reduction of Vascular Events: Pilot Randomized Controlled Trial N/A
Completed NCT02911701 - Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features Phase 4
Completed NCT01911494 - Community Level Interventions for Pre-eclampsia N/A
Terminated NCT02025426 - Phenylephrine Versus Ephedrine in Pre-eclampsia Phase 4
Completed NCT01352234 - Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia Phase 4
Active, not recruiting NCT02031393 - Establishing First Trimester Markers for the Identification of High Risk Twin N/A
Terminated NCT00141310 - Sildenafil Citrate for the Treatment of Established Pre-Eclampsia Phase 2
Completed NCT00157521 - L-Arginine in Pre-Eclampsia Phase 3
Completed NCT04795154 - Prenatal Yoga as Complementary Therapy of Preeclampsia N/A
Completed NCT00004399 - Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia N/A
Completed NCT00005207 - Renin and Prorenin in Pregnancy N/A
Recruiting NCT04551807 - Natural Versus Programmed Frozen Embryo Transfer (NatPro) Phase 3
Terminated NCT04092829 - Impact of Corpus Luteum Presence or Absence in the Incidence of Preeclampsia After Frozen Embryo Transfer N/A
Recruiting NCT06067906 - Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients N/A
Recruiting NCT06317467 - Role of Anti-C1q Autoantibodies in Pregnancy
Completed NCT02218931 - ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes N/A
Active, not recruiting NCT04484766 - Preeclampsia Associated Vascular Aging