NCT05673499

Brief Summary

The goal of this observational study is to determine the incidence of perioperative cerebral desaturation in neonates undergoing surgery for congenital malformations. The main questions it aims to answer are:

  1. 1.The perioperative factors associated with occurrence of cerebral desaturation
  2. 2.The association between perioperative cerebral desaturation, perioperative/hospital outcomes, and physiological conditions.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
7 countries

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Aug 2022Dec 2027

Study Start

First participant enrolled

August 12, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

5.4 years

First QC Date

December 21, 2022

Last Update Submit

April 20, 2026

Conditions

Congenital DisordersCerebral DesaturationNeonatal Surgery

Keywords

ElectroencephalographyNear-infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants with perioperative cerebral desaturation

    The incidence of cerebral desaturation in participants will be assessed by the Near-infrared Spectroscopy (NIRS) data recording of \<70% and/or \>10% decrease from baseline for \> 3 minutes

    24 hours

Secondary Outcomes (2)

  • Isoelectric EEG

    up to 24 hours

  • Perioperative outcomes

    up to 100 days

Study Arms (1)

Infants

Infant subjects ≤ 60 weeks post-menstrual age who are undergoing surgery for congenital malformations

Device: NIRS/EEG monitoring

Interventions

NIRS/EEG monitoringDEVICE

The study intervention will be monitoring NIRS and EEG for one hour before surgery, during surgery, and up to 8-24 hours after surgery.

Infants

Eligibility Criteria

AgeUp to 60 Weeks
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infant subjects ≤ 60 weeks post-menstrual age who are undergoing surgery for congenital malformat

You may qualify if:

  • Infants ≤ 60 weeks post-menstrual age on day of surgery.
  • Neonatal surgery for congenital abdominal/gastrointestinal malformations (diaphragmatic hernia, gastroschisis, omphalocele, intestinal atresia, Hirschsprung's disease, imperforate anus, necrotizing enterocolitis), congenital cystic adenomatoid/pulmonary airway malformation (CCAM/CPAM), esophageal/tracheoesophageal fistula (EF/TEF), and spinal malformations (myelomeningocele, sacrococcygeal teratoma).
  • The same patient may be enrolled multiple times for repeat or different procedures that meet the above criteria. These subjects will be counted more than once towards the enrollment goal.
  • Parental/guardian permission.

You may not qualify if:

  • \) Patients with hydrocephalus limiting frontal-parietal brain volume, interventricular hemorrhage (grades 3 or 4), malformation or cerebral infarction of frontal-parietal brain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Children's Hospital at Montefiore/Albert Einstein College of Medicine

New York, New York, 10467, United States

NOT YET RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

NOT YET RECRUITING

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

NOT YET RECRUITING

Perth Children's Hospital

Nedlands, Australia

RECRUITING

Royal Children's Hospital

Parkville, Australia

NOT YET RECRUITING

Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo

São Paulo, Brazil

RECRUITING

Guangzhou women and children's medical center

Guangzhou, China

NOT YET RECRUITING

Shanghai Children's Medical Center

Shanghai, China

NOT YET RECRUITING

Shengjing Hospital of China Medical University

Shenyang, China

NOT YET RECRUITING

West China Hospital and West China Second University Hospital

Sichuan, China

NOT YET RECRUITING

Centre Hospitalier Universitaire de Bordeaux, Hopital des enfants

Bordeaux, France

NOT YET RECRUITING

Post Graduate Institute of Medical Education and Research

Chandigarh, India

NOT YET RECRUITING

Christian Medical College Hospital

Vellore, India

NOT YET RECRUITING

Great Ormond Street Hospital for Children

London, United Kingdom

NOT YET RECRUITING

Related Publications (20)

  • CDC. https://www.cdc.gov/ncbddd/birthdefects/data.html. Accessed April 13, 2021.

    BACKGROUND

  • Bonasso PC, Dassinger MS, Ryan ML, Gowen MS, Burford JM, Smith SD. 24-hour and 30-day perioperative mortality in pediatric surgery. J Pediatr Surg. 2019 Apr;54(4):628-630. doi: 10.1016/j.jpedsurg.2018.06.026. Epub 2018 Jun 25.

    PMID: 30017066BACKGROUND

  • Laing S, Walker K, Ungerer J, Badawi N, Spence K. Early development of children with major birth defects requiring newborn surgery. J Paediatr Child Health. 2011 Mar;47(3):140-7. doi: 10.1111/j.1440-1754.2010.01902.x. Epub 2010 Nov 21.

    PMID: 21091587BACKGROUND

  • Stolwijk LJ, Lemmers PM, Harmsen M, Groenendaal F, de Vries LS, van der Zee DC, Benders MJ, van Herwaarden-Lindeboom MY. Neurodevelopmental Outcomes After Neonatal Surgery for Major Noncardiac Anomalies. Pediatrics. 2016 Feb;137(2):e20151728. doi: 10.1542/peds.2015-1728. Epub 2016 Jan 12.

    PMID: 26759411BACKGROUND

  • Tusor N, Benders MJ, Counsell SJ, Nongena P, Ederies MA, Falconer S, Chew A, Gonzalez-Cinca N, Hajnal JV, Gangadharan S, Chatzi V, Kersbergen KJ, Kennea N, Azzopardi DV, Edwards AD. Punctate White Matter Lesions Associated With Altered Brain Development And Adverse Motor Outcome In Preterm Infants. Sci Rep. 2017 Oct 16;7(1):13250. doi: 10.1038/s41598-017-13753-x.

    PMID: 29038505BACKGROUND

  • Stolwijk LJ, Keunen K, de Vries LS, Groenendaal F, van der Zee DC, van Herwaarden MYA, Lemmers PMA, Benders MJNL. Neonatal Surgery for Noncardiac Congenital Anomalies: Neonates at Risk of Brain Injury. J Pediatr. 2017 Mar;182:335-341.e1. doi: 10.1016/j.jpeds.2016.11.080. Epub 2016 Dec 30.

    PMID: 28043688BACKGROUND

  • Sood ED, Benzaquen JS, Davies RR, Woodford E, Pizarro C. Predictive value of perioperative near-infrared spectroscopy for neurodevelopmental outcomes after cardiac surgery in infancy. J Thorac Cardiovasc Surg. 2013 Feb;145(2):438-445.e1; discussion 444-5. doi: 10.1016/j.jtcvs.2012.10.033. Epub 2012 Dec 6.

    PMID: 23219333BACKGROUND

  • Hoffman GM, Brosig CL, Mussatto KA, Tweddell JS, Ghanayem NS. Perioperative cerebral oxygen saturation in neonates with hypoplastic left heart syndrome and childhood neurodevelopmental outcome. J Thorac Cardiovasc Surg. 2013 Nov;146(5):1153-64. doi: 10.1016/j.jtcvs.2012.12.060. Epub 2013 Jan 12.

    PMID: 23317941BACKGROUND

  • Vida VL, Tessari C, Cristante A, Nori R, Pittarello D, Ori C, Cogo PE, Perissinotto E, Stellin G. The Role of Regional Oxygen Saturation Using Near-Infrared Spectroscopy and Blood Lactate Levels as Early Predictors of Outcome After Pediatric Cardiac Surgery. Can J Cardiol. 2016 Aug;32(8):970-7. doi: 10.1016/j.cjca.2015.09.024. Epub 2015 Oct 22.

    PMID: 26868838BACKGROUND

  • Danzer E, Hoffman C, D'Agostino JA, Gerdes M, Bernbaum J, Antiel RM, Rintoul NE, Herkert LM, Flake AW, Adzick NS, Hedrick HL. Neurodevelopmental outcomes at 5years of age in congenital diaphragmatic hernia. J Pediatr Surg. 2017 Mar;52(3):437-443. doi: 10.1016/j.jpedsurg.2016.08.008. Epub 2016 Aug 30.

    PMID: 27622588BACKGROUND

  • Birthdefects C. https://www.cdc.gov/ncbddd/birthdefects/data.html. Published 2021. Accessed April 21, 2021.

    BACKGROUND

  • Escobar MA Jr, Caty MG. Complications in neonatal surgery. Semin Pediatr Surg. 2016 Dec;25(6):347-370. doi: 10.1053/j.sempedsurg.2016.10.005. Epub 2016 Nov 1.

    PMID: 27989360BACKGROUND

  • Andropoulos DB, Ahmad HB, Haq T, Brady K, Stayer SA, Meador MR, Hunter JV, Rivera C, Voigt RG, Turcich M, He CQ, Shekerdemian LS, Dickerson HA, Fraser CD, Dean McKenzie E, Heinle JS, Blaine Easley R. The association between brain injury, perioperative anesthetic exposure, and 12-month neurodevelopmental outcomes after neonatal cardiac surgery: a retrospective cohort study. Paediatr Anaesth. 2014 Mar;24(3):266-74. doi: 10.1111/pan.12350.

    PMID: 24467569BACKGROUND

  • Mahle WT, Tavani F, Zimmerman RA, Nicolson SC, Galli KK, Gaynor JW, Clancy RR, Montenegro LM, Spray TL, Chiavacci RM, Wernovsky G, Kurth CD. An MRI study of neurological injury before and after congenital heart surgery. Circulation. 2002 Sep 24;106(12 Suppl 1):I109-14.

    PMID: 12354718BACKGROUND

  • Olbrecht VA, Skowno J, Marchesini V, Ding L, Jiang Y, Ward CG, Yu G, Liu H, Schurink B, Vutskits L, de Graaff JC, McGowan FX Jr, von Ungern-Sternberg BS, Kurth CD, Davidson A. An International, Multicenter, Observational Study of Cerebral Oxygenation during Infant and Neonatal Anesthesia. Anesthesiology. 2018 Jan;128(1):85-96. doi: 10.1097/ALN.0000000000001920.

    PMID: 29019815BACKGROUND

  • Dent CL, Spaeth JP, Jones BV, Schwartz SM, Glauser TA, Hallinan B, Pearl JM, Khoury PR, Kurth CD. Brain magnetic resonance imaging abnormalities after the Norwood procedure using regional cerebral perfusion. J Thorac Cardiovasc Surg. 2006 Jan;131(1):190-7. doi: 10.1016/j.jtcvs.2005.10.003.

    PMID: 16399311BACKGROUND

  • Suemori T, Skowno J, Horton S, Bottrell S, Butt W, Davidson AJ. Cerebral oxygen saturation and tissue hemoglobin concentration as predictive markers of early postoperative outcomes after pediatric cardiac surgery. Paediatr Anaesth. 2016 Feb;26(2):182-9. doi: 10.1111/pan.12800. Epub 2015 Dec 1.

    PMID: 26619804BACKGROUND

  • Kurth CD, Levy WJ, McCann J. Near-infrared spectroscopy cerebral oxygen saturation thresholds for hypoxia-ischemia in piglets. J Cereb Blood Flow Metab. 2002 Mar;22(3):335-41. doi: 10.1097/00004647-200203000-00011.

    PMID: 11891439BACKGROUND

  • Yuan I, Xu T, Kurth CD. Using Electroencephalography (EEG) to Guide Propofol and Sevoflurane Dosing in Pediatric Anesthesia. Anesthesiol Clin. 2020 Sep;38(3):709-725. doi: 10.1016/j.anclin.2020.06.007.

    PMID: 32792193BACKGROUND

  • Yuan I, Olbrecht VA, Mensinger JL, Zhang B, Davidson AJ, von Ungern-Sternberg BS, Skowno J, Lian Q, Song X, Zhao P, Zhang J, Zhang M, Zuo Y, de Graaff JC, Vutskits L, Szmuk P, Kurth CD. Statistical Analysis Plan for "An international multicenter study of isoelectric electroencephalography events in infants and young children during anesthesia for surgery". Paediatr Anaesth. 2019 Mar;29(3):243-249. doi: 10.1111/pan.13589.

    PMID: 30664323BACKGROUND

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Charles Dean Kurth, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paula Hu, RN, MSPH

CONTACT

267-426-2961hup@chop.edu

Elizabeth Ramsay

CONTACT

267-270-5087ramsaye2@chop.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 6, 2023

Study Start

August 12, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

BR(1)GB(1)FR(1)AU(2)US(4)CN(4)IN(2)