A first-in-human clinical study of a new SP-B and SP-C enriched synthetic surfactant (CHF5633) in preterm babies with respiratory distress syndrome: two-year outcomes.
J Matern Fetal Neonatal Med
; 35(24): 4739-4742, 2022 Dec.
Article
in En
| MEDLINE
| ID: mdl-33345663
ABSTRACT
OBJECTIVE:
To assess at 24 months corrected age (CA) the neurological, respiratory, and general health status of children born prematurely from 27+0 to 33+6 weeks' gestation who were treated in a first-in-human study with a new fully synthetic surfactant (CHF5633) enriched with SP-B and SP-C proteins. OUTCOMEMEASURES:
Children were assessed using Bayley Scales of Infant Development (BSID), with a score below normal defined as BSID-II Mental Development Index score <70, or BSID-III cognitive composite score <85. In addition, a health status questionnaire was used to check for functional disability including respiratory problems and related treatments, sensory and neurodevelopment assessments, communication skills as well as the number of hospitalizations.RESULTS:
35 of 39 survivors had a neurodevelopmental assessment, 24 infants being evaluated by Bayley's Scales and 11 by health status questionnaires only. 23 children had scores within normal limits and one had BSID-III <85. The remaining 11 were judged clinically to have normal development. Health status questionnaires detected only issues that would normally be expected in preterm-born children.CONCLUSIONS:
This assessment offers reassurance that treatment with CHF5633 surfactant was not associated with adverse neurodevelopmental, respiratory, or health outcomes by two years corrected age.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Respiratory Distress Syndrome, Newborn
/
Infant, Premature, Diseases
Aspects:
Patient_preference
Limits:
Child, preschool
/
Humans
/
Infant
/
Newborn
Language:
En
Journal:
J Matern Fetal Neonatal Med
Journal subject:
OBSTETRICIA
/
PERINATOLOGIA
Year:
2022
Document type:
Article