Intraventricular Haemorrhage (IVH) and Post-haemorrhagic Ventricular Dilatation (PHVD) in premature infants born before 37 weeks of gestational age Pregnancy and Childbirth
Conditions
Interventions
This is a phase III, multi-centre, randomised, assessor-blinded, controlled trial of NEL with temporising device (intervention Arm A) vs temporising device alone (standard treatment/Control Arm B).
A
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
22 Weeks to 36.85 Weeks
Inclusion criteria
Inclusion criteria: 1. Premature infants born before 37 weeks of gestational age 2. IVH: Papile Grades II-IV on cranial ultrasound scan 3. PHVD: Ventricular index at or beyond the threshold point of the 97th centile for gestational age plus 4 mm on the Levene chart despite 2 attempted lumbar or ventricular punctures.
Exclusion criteria
Exclusion criteria: 1. Infants with coagulopathy (INR > 1.6) or platelet disorders (platelet count under 80,000/mL) that persist on attempted correction. Clinical judgement will be made by the Investigator. 2. Infants deemed too unstable for neurosurgical intervention. This is a clinical judgement made by the responsible neurosurgeon, neonatologist and anaesthetic team. 3. Parents or carers unwilling to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive Quotient (CQ) measured by the Bayley Scales of Infant and Toddler Development Fourth Edition (Bayley IV) at 2 years’ corrected age (+/- 2 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Developmental measures: 1.1. Motor quotient (MQ): Age equivalent motor score of the Bayley IV divided by corrected age at assessment, measured at 2 years’ corrected age 1.2. Language quotient (LQ): Age equivalent language score of the Bayley IV divided by corrected age at assessment, measured at 2 years’ corrected age 2. Other neurological and functional assessments conducted during the 2-year follow-up visit: 2.1. Presence of seizures during the first 2 years and use of anticonvulsant medication at 2 years 2.2. Presence of cerebral palsy (+ accompanying Gross Motor Function Classification System (GMFCS) grade and deficit distribution map using the Classification of SCPE 2.3. Assessment of hearing and vision (British Association of Perinatal Medicine classification) at 2 years’ corrected age 2.4. Parent report at 2 years’ corrected age: 2.4.1. Brief Infant Toddler Social Emotional Assessment (BITSEA) 2.4.2. Quantitative Checklist for Autism in Toddlers (Q-CHAT) 3. Mortality up to 2 years corrected age 4. NEL and VP shunt related outcomes: 4.1. Safety of NEL, measured by the number of Adverse Events reported until 2 years’ corrected age 4.2. Number and type of further surgical procedures required until 2 years’ corrected age 4.3. Requirement for permanent VP shunt insertion at 6 months’ corrected age 5. Quality of life and health economic assessments: 5.1. Health-related quality of life (HRQoL) in children measured using the TNO-AZL Preschool Children’s Quality of Life (TAPQOL) at 12 months and 2 years’ corrected age 5.2. HRQoL in primary caregiver measured using the EuroQoL EQ-5D-5L at baseline, 6 months, 12 months and 2 years’ corrected age 5.3. Healthcare resource use costs (CSRI (adapted) children version) at 3, 6, 12, 18 months and 2 years’ corrected age 5.4. Subsequent cost-effectiveness analysis and cost-benefit analysis of impact on carers based on responses to the EQ-5D-5L | — |
Countries
England, United Kingdom
Contacts
Public ContactSue Massingham
Outcome results
None listed