NCT02034617: LiMoNid

Evaluation of a Parent-Infant Interaction Model

Completed NA Last updated 11 June 2024

What this trial tests

NA trial testing LiMoNid in Premature Birth in 140 participants. Completed in 31 May 2024.

Timeline

1 January 2014

Primary endpoint
31 August 2021

31 May 2024

Quick facts

Lead sponsor	Linkoeping University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	140
Start date	1 January 2014
Primary completion	31 August 2021
Estimated completion	31 May 2024
Sites	1 location across Sweden

Drugs / interventions tested

• LiMoNid

Conditions studied

• Premature Birth — all drugs for Premature Birth →

Sponsor

Linkoeping University

Who can join

Under 96 Hours, any sex, with Premature Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

When becoming a parent of a preterm infant there is an increased risk of stress. There are a number of studies showing that parental stress has a negative impact on their engagement with their child. Other studies, on the other hand, show that different intervention programs with the aim to strengthen the relationship can decrease parental stress and hence affect the parent-infant interaction in a positive way. Structured intervention programs for preterm infants have also been successful in improving the infants' cognitive functions.

The investigators have developed a program with the aim to strengthen the parent-infant interaction for late preterm infants. The observational program is called LiMoNid. Our hypothesis is that LiMoNid will strengthen the parents' own parental abilities and give them a deeper understanding of their child. They will hopefully develop more skills on how to communicate with their child; to see, interpret, understand and approach the child, which can lead to an improved parent-child interaction. Parental stress may also be reduced by increased understanding and control. Regarding the child itself, we hypothesize that the psychological development will be affected depending on the communication with the caregiver and depending on the support it has received in expressing its feelings and needs. The emotional regulation should be strengthened by such an intervention.

The aim is to study if LiMoNid can have an impact on cognition, stress, parent-child interaction.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness and family experiences of interventions promoting partnerships between families and pediatric and neonatal intensive care units: a mixed methods systematic review.
   Barnes S, Macdonald I, Rahmaty Z, de Goumoëns V, et al · · 2024 · cited 10× · PMID 38505961 · DOI 10.11124/jbies-23-00034
2. An Early Collaborative Intervention Focusing on Parent-Infant Interaction in the Neonatal Period. A Descriptive Study of the Developmental Framework.
   Helmer CS, Thornberg UB, Mörelius E. · · 2021 · cited 8× · PMID 34205660 · DOI 10.3390/ijerph18126656
3. Moderate-To-Late Preterm Infants Benefit From the Early Collaborative Intervention: Primary Outcomes of an RCT.
   Birberg Thornberg U, Koch FS, Helmer CS, Tell J, et al · · 2025 · cited 1× · PMID 40511708 · DOI 10.1111/apa.70173
4. Impacts of the Early Collaborative Intervention on mother-preterm infant interaction at one month of age: Secondary analysis of a randomized controlled trial.
   Helmer CS, Thornberg UB, Abrahamsson T, Mörelius E. · · 2026 · PMID 41782918 · DOI 10.1016/j.ijnsa.2026.100507