Association between cerebral oxygenation and activity as evaluated perioperative by NIRS and aEEG and evaluation of growth and neurodevelopment within the first two years of age.
ID
Bron
Verkorte titel
Aandoening
Surgical repair of Congenital Diaphragmatic Hernia or Esophageal Atresia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The overall aim is to evaluate the association between cerebral oxygenation and activity as
evaluated perioperative by NIRS and aEEG and evaluation of growth and neurodevelopment
within the first two years of age.
Achtergrond van het onderzoek
RATIONALE: Traditional open surgical management of congenital diaphragmatic hernia (CDH)
and esophageal atresia (EA) consists of either laparotomy or thoracotomy. Minimal access
surgery has gained popularity in the last decade because of its potential benefits. The outcome of
thoracoscopic surgery is still in discussion and the long-term effects on neurodevelopment are
unknown. Patch repair is feasible thoracoscopically, but more difficult and time consuming.
OBJECTIVES: To evaluate the significance of non-invasive neuromonitoring (NIRS and aEEG)
during surgical repair and the evaluation of growth and neurodevelopment within the first 2
years of life.
STUDY DESIGN: Multi-centre observational prospective study.
STUDY POPULATION: Neonates meeting the criteria for surgical repair of CDH. In Rotterdam
neonates meeting the criteria for surgical repair of EA can also be included in the study protocol.
INTERVENTION: Non-invasive neuromonitoring of CDH and EA neonates
PRIMARY STUDY PARAMETERS: Association between cerebral oxygenation and activity as
evaluated perioperative by NIRS and aEEG and evaluation of growth and neurodevelopment
within the first two years of age.
SECONDARY STUDY PARAMETERS: Changes in cerebral oxygenation and activity as evaluated
by NIRS and aEEG and a comparison between open and minimal access surgery of the
diaphragm defect. Arterial blood gas analysis, tissue oxygenation and transcutaneous CO2
measurements during surgery. Prenatal screening ultrasound results for CDH. Pre- and
postoperative intensive care management such as ventilation settings, need of oxygen and use of
vasoactive medication, ventilator free days at day 28, postoperative pain scores every eight
hours (COMFORT scores), length of hospital stay recurrence rate in the two years after surgery
and cranial ultrasound pre- and postoperative and at discharge and 1 year old.
Doel van het onderzoek
Association between cerebral oxygenation and activity as evaluated perioperative by NIRS and aEEG and evaluation of growth and neurodevelopment within the first two years of age.
Onderzoeksopzet
During admission and at 6, 12, 18 and 30 months
Onderzoeksproduct en/of interventie
Neuromonitor perioperative by NIRS and aEEG
Algemeen / deelnemers
S. Costerus
Rotterdam
The Netherlands
s.costerus@erasmusmc.nl
Wetenschappers
S. Costerus
Rotterdam
The Netherlands
s.costerus@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Surgical repair of the diaphragmatic and esophageal defect should be performed after clinical
stabilization, defined as follows:
- Mean arterial blood pressure normal for gestation.
- Preductal saturation levels of 85–95% on FiO2 below 50%
- Lactate below 3 mmol/l
- Urine output more than 1 ml/kg/h
Repair can be performed while the patient is on ECMO
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Associated major cardiac anomalies/chromosomal anomalies or syndromes with major
cognitive impairment excluding surgical repair of the diaphragmatic defect due to futility.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6972 |
| NTR-old | NTR7160 |
| CCMO | NL59526.078.17 |
| OMON | NL-OMON49066 |