Premature BirthLiMoNidNCT02034617
Evaluation of a Parent-Infant Interaction Model
A study testing LiMoNid in people with Premature Birth, run by Linkoeping University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 96 hours
- Conditions the study is for
- Premature Birth
- What is being tested?
- LiMoNid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2014to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 96 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants born 30-36 weeks gestational age without known major malformations or complications
- Families living in the county of Ostergotland, Sweden
- Swedish speaking parents
- Single or duplex birth
Who cannot join
- Complications encountered during hospital stay that are known to affect cognition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Parent-Infant Interaction Model in the Neonatal Intensive Care
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.
Read the detailed description
The Design is a randomised controlled study in two groups; intervention group versus standard care. Parents who meet the inclusion criteria are given oral and written information about the study aim and procedure and are asked for participation. If the parents consent they will be randomised to one of two groups. Follow-ups will be conducted at 1 month, 4 months, 10-12 months corrected age and when the child is 4 years.
- Conditions
- Premature Birth
- Being tested
- LiMoNid
- Keywords
- Cognition, Family nursing, Infant, premature, Object attachment, Stress, physiological, Stress, psychological
- Medical subject headings
- Premature Birth, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiMoNidBehavioural
One LiMoNid observation will be performed on day 1-3 post birth, one in time of discharge, and one in the home when the infant has reached 40 weeks (+/- 2 week). All observations are performed in presence of and in collaboration with the parents with the outspoken aim to guide the parents to learn how to read and respond to their infant' signals
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | The family receive standard care when enrolled in the Neonatal intensive care unit |
| Observation | Experimental | The family receive standard care when enrolled in the Neonatal intensive care unit and are also included in an observational program called LiMoNid. Receives: Behavioral: LiMoNid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive abilities
Bayley Scales of Infant Development
Measured: 11 months
Secondary outcomes (1)
Stress reactivity
Salivary cortisol reactivity in relation to bath
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study start1 Jan 2014
- Primary completion31 Aug 2021
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Evalotte Morelius, Linkoeping University
- Investigators
- Evalotte Morelius, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034617
- Sponsor's protocol ID
- LinkoepingU
- Acronym
- LiMoNid
- Status last verified
- Jun 2024
- First submitted
- 19 Dec 2013
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Helmer CS, Thornberg UB, Abrahamsson T, Morelius E. Mothers' experiences of a new early collaborative intervention, the EACI, in the neonatal period: A qualitative study. J Clin Nurs. 2023 Jun;32(11-12):2892-2902. doi: 10.1111/jocn.16412. Epub 2022 Jun 14.
PubMed 35702001Helmer CS, Thornberg UB, Morelius E. An Early Collaborative Intervention Focusing on Parent-Infant Interaction in the Neonatal Period. A Descriptive Study of the Developmental Framework. Int J Environ Res Public Health. 2021 Jun 21;18(12):6656. doi: 10.3390/ijerph18126656.
PubMed 34205660Helmer CS, Thornberg UB, Abrahamsson T, Morelius E. Impacts of the Early Collaborative Intervention on mother-preterm infant interaction at one month of age: Secondary analysis of a randomized controlled trial. Int J Nurs Stud Adv. 2026 Feb 9;10:100507. doi: 10.1016/j.ijnsa.2026.100507. eCollection 2026 Jun.
PubMed 41782918Birberg Thornberg U, Koch FS, Helmer CS, Tell J, Nyberg E, Abrahamsson T, Morelius E. Moderate-To-Late Preterm Infants Benefit From the Early Collaborative Intervention: Primary Outcomes of an RCT. Acta Paediatr. 2025 Nov;114(11):2838-2846. doi: 10.1111/apa.70173. Epub 2025 Jun 13.
PubMed 40511708
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Parent-Infant Interaction Model in the Neonatal Intensive Care
- ClinicalTrials.gov ID
- NCT02034617
- Acronym / sponsor ID
- LiMoNid / LinkoepingU
- Conditions
- Premature Birth
- Keywords
- Cognition, Family nursing, Infant, premature, Object attachment, Stress, physiological, Stress, psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Design is a randomised controlled study in two groups; intervention group versus standard care. Parents who meet the inclusion criteria are given oral and written information about the study aim and procedure and are asked for participation. If the parents consent they will be randomised to one of two groups. Follow-ups will be conducted at 1 month, 4 months, 10-12 months corrected age and when the child is 4 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –The family receive standard care when enrolled in the Neonatal intensive care unit |
| Observation | Experimental | Behavioral: LiMoNidThe family receive standard care when enrolled in the Neonatal intensive care unit and are also included in an observational program called LiMoNid. |
Who may qualify
- Ages
- Up to 96 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm infants born 30-36 weeks gestational age without known major malformations or complications
- Families living in the county of Ostergotland, Sweden
- Swedish speaking parents
- Single or duplex birth
Key exclusion criteria (1 listed)
- Complications encountered during hospital stay that are known to affect cognition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiMoNidOne LiMoNid observation will be performed on day 1-3 post birth, one in time of discharge, and one in the home when the infant has reached 40 weeks (+/- 2 week). All observations are performed in presence of and in collaboration with the parents with the outspoken aim to guide the parents to learn how to read and respond to their infant' signals | Behavioural | Observation |
Primary outcome
Cognitive abilities
Time frame: 11 months
Bayley Scales of Infant Development
1 secondary outcome
Stress reactivity
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Results publication: PubMed 35702001Helmer CS, Thornberg UB, Abrahamsson T, Morelius E. Mothers' experiences of a new early collaborative intervention, the EACI, in the neonatal period: A qualitative study. J Clin Nurs. 2023 Jun;32(11-12):2892-2902. doi: 10.1111/jocn.16412. Epub 2022 Jun 14.
- Results publication: PubMed 34205660Helmer CS, Thornberg UB, Morelius E. An Early Collaborative Intervention Focusing on Parent-Infant Interaction in the Neonatal Period. A Descriptive Study of the Developmental Framework. Int J Environ Res Public Health. 2021 Jun 21;18(12):6656. doi: 10.3390/ijerph18126656.
- Derived from this study: PubMed 41782918Helmer CS, Thornberg UB, Abrahamsson T, Morelius E. Impacts of the Early Collaborative Intervention on mother-preterm infant interaction at one month of age: Secondary analysis of a randomized controlled trial. Int J Nurs Stud Adv. 2026 Feb 9;10:100507. doi: 10.1016/j.ijnsa.2026.100507. eCollection 2026 Jun.
- Derived from this study: PubMed 40511708Birberg Thornberg U, Koch FS, Helmer CS, Tell J, Nyberg E, Abrahamsson T, Morelius E. Moderate-To-Late Preterm Infants Benefit From the Early Collaborative Intervention: Primary Outcomes of an RCT. Acta Paediatr. 2025 Nov;114(11):2838-2846. doi: 10.1111/apa.70173. Epub 2025 Jun 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evalotte Morelius, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiMoNid in people with Premature Birth, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive abilities (time frame: 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02034617, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.