Novel Epigenetic Biomarker for Prematurity Related Neurodevelopmental Disorders in Childhood

NACompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

December 3, 2020

Primary Completion Date

March 21, 2025

Study Completion Date

March 30, 2025

Conditions
Premature Birth
Interventions
BEHAVIORAL

Early Intervention

The early intervention (EI) is delivered during the NICU stay. It is a multisensory intervention which consists in three parts: parental training, massage therapy and visual interaction. The EI is first focused on parental training, according to PremieStart Protocol, in order to train parents to: recognize signs of infant stress and alert-available behavior through the identification of infant's behavioral states; adopt principles of graded stimulation; sustain infant's attention and respond to infant's cues; optimize interactions and avoid overwhelming infants through facilitation strategies. The program is held in eight main sessions and one additional post-discharge session. In addition, parents are trained and invited to daily promote preterm baby massage therapy and visual interaction (visual fixation/tracking and visual attention).

Trial Locations (1)

20122

NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan

All Listed Sponsors
collaborator

Ministero della Salute, Italy

OTHER

collaborator

Istituto Nazionale di Genetica Molecolare, Milan Italy

UNKNOWN

collaborator

IRCCS Humanitas Milan Italy

UNKNOWN

lead

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

NCT04617587 - Novel Epigenetic Biomarker for Prematurity Related Neurodevelopmental Disorders in Childhood | Biotech Hunter | Biotech Hunter