Developmental Care Program in Neonatal Intensive Care Unit

Premature Birth Clinical Trial

— CIN  

Official title:

Developmental Family Centred Care Program in Neonatal Intensive Care Unit

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05573945
• Other study ID #: CIN
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project is a Randomised Clinical Trial that includes a family centred education intervention and/or non-directive active listening counselling intervention with families of preterm infants at risk for sensori-motor disorders.

Description:

Preterm babies, specifically with gestational age < 33+6 weeks, will be recruited and assigned (randomized) into an a Family Education + Active Listening Group (intervention A) or a Family Education Only Group (intervention B).

When the clinical condition of the child is stable the parents are approached for consent and randomised.

All families (in intervention A and intervention B) will receive the evidence-based program of Family Education which is based on the promotion of the parent-child relationship through the recognition of behavioral states, methods of interaction, facilitation strategies in the relationship.

It takes its conceptual basis from the Mother Infant Transaction Program (MITP). It is a specific and re-adapted version for the preterm infant hospitalized in NICU The family education sessions involve about 6 meetings (1-2 a week) of 30-45 minutes that are carried out during the hospitalization in the NICU directly at the child's bed between the operator and one or both parents. Each meeting involves the discussion of one of the following topics.

The Families in intervention group A will also receive 4-6 weekly meetings with a psychologist for an active listening counselling session.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: December 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Week to 10 Weeks

Eligibility

Inclusion Criteria:

• Parents of preterm <34 weeks without brain lesion

Exclusion Criteria:

• Parents of infants with brain Lesions

• Parents of clinically unstable infants, based on standard medical evaluation of preterm infants (eg: children with mechanical ventilation or under sedation)

• Parents of infants with genetic-malformative conditions

• Parents with severe psychiatric disorders

Related Conditions & MeSH terms

• Premature Birth

Intervention

Behavioral:
• Family Education and Active Listening
Bedside intervention directly with infant with trained healthcare providers and parents. Includes family education meetings completed with individual infant parent/s and trained operator. In addition, weekly meetings of parent/s with a psychologist in a private location for an active listening counselling session.
• Family Education
Bedside intervention directly with infant with trained healthcare providers and parents. Includes family education meetings completed with individual infant parent/s and trained operator.

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Stella Maris	Pisa	PI

Sponsors (3)

Lead Sponsor	Collaborator
University of Pisa	Azienda Ospedaliero, Universitaria Pisana, IRCCS Fondazione Stella Maris

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	General Movements (GM)	The General Movements Assessment (GMA), an observation of infant spontaneous movements will be completed and scored based on a standard protocol of GMA. The observation allows for the understanding of the neurological risk category for neuromotor difficulties.	10-16 weeks corrected age
Primary	Parent Infant interaction behaviours coding	Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system.	1 months corrected age
Primary	Parent Infant interaction behaviours coding	Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system.	3 months corrected age
Primary	Parent Infant interaction behaviours coding	Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system.	6 months corrected age
Primary	Developmental outcome assessment	Bayley Scales of Infant Development Third Edition will be conducted including the Cognitive, Language (Receptive & Expressive), Motor (Gross & Fine), Social-Emotional and Adaptive sub scales. Each sub scale score will be calculated based on the age (months of age) of the infant at the time assessment. Higher scores mean a better outcome.	12 months corrected age
Secondary	Family well-being questionnaires	The Infant Toddler Quality of Life QuestionnaireTM (ITQOL)	Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
Secondary	Family well-being questionnaire	Edinburg Postnatal Depression Scale (EPDS)	Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
Secondary	Family well-being questionnaire	Depression Anxiety Stress Scale (DASS-21)	Frame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
Secondary	Family well-being questionnaire	Coping Orientation to Problems Experienced (COPE - NVI)	Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age