Early Intervention in Preterm Infants: Short and Long Term Developmental Outcome After a Parental Training Program

NCT02983513 | Completed

• 1 other identifier: MITP Preterm
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm infants, during their stay in the Neonatal Intensive Care Unit (NICU), face a period of stressful environment, which may negatively impact early brain development and subsequent neurobehavioral outcomes. This study aims to assess the effectiveness of training parents in reducing stressful experiences early in life and in enhancing brain development and long term developmental outcomes.

Conditions

Premature Birth

Keywords

Early intervention; Brain Development; Neurodevelopment

Outcome Measures

Primary Outcomes (2)

• Neonatal Visual Assessment Battery to evaluate visual function

  Neonatal Visual Function is assessed using the Visual Assessment Battery developed by Ricci et al. The assessment evaluates the following items: Ocular spontaneous motility, ability to fix and follow a target, reaction to colour, visual acuity and visual attention at distance. Each item is scored as normal (score 0) or abnormal (score 1). The global score is then calculated as the sum of all the individual items, as designed by the authors.

  40 weeks postmenstrual age

• Neonatal Behavior

  Neonatal behavior is assessed using the Neonatal Behavior Assessment Scale that evaluates: habituation, social-interactive, motor system, state organization and regulation, autonomic system, reflexes.

  2 months corrected age

Secondary Outcomes (14)

• Brain development

  40 weeks postmenstrual age

• Developmental outcome

  24 months corrected age

• Epigenetic changes

  up to 48 weeks gestational age

• overall duration of hospitalisation

  up to 48 weeks gestational age

• Weight (in grams) at 40 weeks postmenstrual age

  40 week gestational age

Study Arms (2)

Early Intervention

EXPERIMENTAL

The early intervention program is delivered during the NICU stay, according to the MITP and Premie Start Protocol, in order to train parents to: recognize signs of infant stress and alert-available behavior to promote mother-infant interaction; adopt principles of graded stimulation; optimize interactions and avoid overwhelming infants through facilitation strategies (for example, engage and support the visual attention of the newborn). 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 attention according to a detailed protocol.

Behavioral: Early Intervention

Standard Care

NO INTERVENTION

Standard Care according to NICU protocols including Kangaroo Mother Care, nesting and minimal handling

Interventions

Early Intervention BEHAVIORAL

Early Intervention

Eligibility Criteria

• Age: 25 Weeks - 29 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age between 25+0 and 29+6 weeks

You may not qualify if:

• major brain lesions as documented by cranial ultrasound (intraventricular hemorrhage \> 2 grade, cystic periventricular leukomalacia)
• neurosensorial deficits (retinopathy of prematurity \> stage 2)
• genetic syndromes and/or major congenital malformations
• major neonatal comorbidities

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (8)

• Newnham CA, Milgrom J, Skouteris H. Effectiveness of a modified Mother-Infant Transaction Program on outcomes for preterm infants from 3 to 24 months of age. Infant Behav Dev. 2009 Jan;32(1):17-26. doi: 10.1016/j.infbeh.2008.09.004. Epub 2008 Nov 20.

  PMID: 19026450 BACKGROUND

• Provenzi L, Fumagalli M, Sirgiovanni I, Giorda R, Pozzoli U, Morandi F, Beri S, Menozzi G, Mosca F, Borgatti R, Montirosso R. Pain-related stress during the Neonatal Intensive Care Unit stay and SLC6A4 methylation in very preterm infants. Front Behav Neurosci. 2015 Apr 21;9:99. doi: 10.3389/fnbeh.2015.00099. eCollection 2015.

  PMID: 25941480 BACKGROUND

• Guzzetta A, D'Acunto MG, Carotenuto M, Berardi N, Bancale A, Biagioni E, Boldrini A, Ghirri P, Maffei L, Cioni G. The effects of preterm infant massage on brain electrical activity. Dev Med Child Neurol. 2011 Sep;53 Suppl 4:46-51. doi: 10.1111/j.1469-8749.2011.04065.x.

  PMID: 21950394 BACKGROUND

• Ricci D, Cesarini L, Romeo DM, Gallini F, Serrao F, Groppo M, De Carli A, Cota F, Lepore D, Molle F, Ratiglia R, De Carolis MP, Mosca F, Romagnoli C, Guzzetta F, Cowan F, Ramenghi LA, Mercuri E. Visual function at 35 and 40 weeks' postmenstrual age in low-risk preterm infants. Pediatrics. 2008 Dec;122(6):e1193-8. doi: 10.1542/peds.2008-1888.

  PMID: 19047222 BACKGROUND

• Ricci D, Romeo DM, Serrao F, Cesarini L, Gallini F, Cota F, Leone D, Zuppa AA, Romagnoli C, Cowan F, Mercuri E. Application of a neonatal assessment of visual function in a population of low risk full-term newborn. Early Hum Dev. 2008 Apr;84(4):277-80. doi: 10.1016/j.earlhumdev.2007.10.002. Epub 2007 Nov 8.

  PMID: 17996405 BACKGROUND

• Fontana C, Provitera L, Bonfanti C, Schiavolin P, Polimeni B, Marasca F, Pesenti N, Iuliano R, Gangi S, Bodega B, Fumagalli M. Neurodevelopmental outcome at 5 to 6 years of age of an early intervention program in preterm infants. Sci Rep. 2025 Dec 2;15(1):45786. doi: 10.1038/s41598-025-28564-8.

  PMID: 41331309 DERIVED

• Fontana C, Marasca F, Provitera L, Mancinelli S, Pesenti N, Sinha S, Passera S, Abrignani S, Mosca F, Lodato S, Bodega B, Fumagalli M. Early maternal care restores LINE-1 methylation and enhances neurodevelopment in preterm infants. BMC Med. 2021 Feb 5;19(1):42. doi: 10.1186/s12916-020-01896-0.

  PMID: 33541338 DERIVED

• Fontana C, De Carli A, Ricci D, Dessimone F, Passera S, Pesenti N, Bonzini M, Bassi L, Squarcina L, Cinnante C, Mosca F, Fumagalli M. Effects of Early Intervention on Visual Function in Preterm Infants: A Randomized Controlled Trial. Front Pediatr. 2020 Jun 4;8:291. doi: 10.3389/fped.2020.00291. eCollection 2020.

  PMID: 32582595 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Monica Fumagalli, MD

  Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: December 6, 2016
• Study Start: April 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: January 1, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)