Developmental Care Program in Neonatal Intensive Care Unit (CIN)

U

University of Pisa

Status

Invitation-only

Conditions

Premature Birth

Treatments

Behavioral: Family Education
Behavioral: Family Education and Active Listening

Study type

Interventional

Funder types

Other

Identifiers

NCT05573945
CIN

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

1 to 10 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

Family Education Only
Experimental group
Description:
Family Education Only. Parents will be asked to participate in an evidence based program s that includes 6-8 visits with a a trained healthcare provider. This program of early intervention based on the promotion of the parent-child relationship through the recognition of behavioral states, methods of interaction, facilitation strategies in the relationship. Active listening Visits includes a cycle of 5-6 consecutive meetings lasting about an hour. The meetings will take place in a defined and dedicated space (private room) or if possible (if no other parents are present) at the baby's cradle. The meeting will take place between a single parent and a trained direct operator. This is not a psychotherapeutic intervention but a support that is provided to the parent. The support is mainly based on active listening, on the problems posed by the parent and on the subject's empowerment.
Treatment:
Behavioral: Family Education and Active Listening
Family Education and Active Listening
Active Comparator group
Description:
Family Education and Active Listening. Parents of infants will be asked to participate in an evidence based program for parents of NICU infants that includes 6-8 visits with a a trained healthcare provider operator. This evidence-based program of early intervention based on the promotion of the parent-child relationship through the recognition of behavioral states, methods of interaction, facilitation strategies in the relationship. The program takes its conceptual basis from the Mother Infant Transaction Program (MITP). It involves about 6 meetings (1-2 a week) of 30-45 minutes that are carried out during the hospitalisation in the NICU directly at the child's bed between the operator and one or both parents.
Treatment:
Behavioral: Family Education

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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