Best Start Trial: early intervention physiotherapy to improve motor outcomes in infants at high risk of cerebral palsy or motor delay

Not Applicable

Active, not recruiting

• Conditions: Abnormal brain imaging findings; Intra-uterine growth retardation (IUGR) less than or equal to the 3rd centile.; Term infants with hypoxic ischaemic encephalopathy (HIE); Seizures; Prematurity les than or equal to 27+6 weeks gestational age; Significant post-natal infections; Neurological - Other neurological disorders; Chronic lung disease (CLD) who received post-natal dexamethasone; Abnormal General Movements scored at term age.; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12619000847112
• Lead Sponsor: Royal North Shore Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-14
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

The key inclusion criteria are (i) Infants deemed at risk of CP and (ii) parents likely to uptake parent-administered interventions for their infants and (iii) infants deemed likely to benefit from motor learning interventions. The criteria for eligibility include:
1. Any preterm or term Infant with other identifiable risk factors such as
(i) Grade 3 or 4 intra-ventricular haemorrhage (IVH), periventricular leukomalacia (PVL) and cystic PVL, periventricular infarction, lesions of the basal ganglia and thalamus, unilateral parenchymal injury, cortical malformation or other MRI identified brain injury eg ischaemic injury
(ii) seizures
(iii) significant post-natal infections infection such as meningitis, blood culture positive gram negative septicaemia or other congenitial TORCH infections (Toxoplasmosis, other [syphilis, varicella-zoster, parvovirus B19], Rubella, Cytomegalovirus (CMV), and Herpes infections).
(iv) chronic lung disease (CLD) who received post-natal dexamethasone
(v) Intra-uterine growth retardation (IUGR) = 3rd centile.
(vi) Abnormal General Movements assessment scoring cramped synchronous at term age in the Writhing movements” period

2. Term infants with hypoxic ischaemic encephalopathy (HIE): Sarnat Stage 2 (moderate) or Sarnat Sage 3 (severe) or MRI identified brain injury

3. Preterm infants less than or equal to 27+6 weeks gestational age.

Exclusion Criteria

1. Parents unable to understand and speak English.
2. Infants with syndromes, cortical visual impairment (detected using the RICCI scale).
3. Retinopathy of Prematurity (ROP) Grade 3.
4. Significant auditory impairment.
5. Infants having undergone major surgery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified