Family Involvement/EmpowermentFINCNCT07364903
Effectiveness of Family-Integrated Newborn Care to Improve Outcomes for Preterm and Low-birth-weight Neonates
A study testing Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates and Standard medical treatment in people with Family Involvement/Empowerment and Family-centered Care, run by Laerdal Foundation at 2 sites in Ethiopia.
Trial summary
The goal of this quasi-experimental study is to learn if integrating family in newborn care units as a key partner can improve the outcomes of preterm and low-birth-weight neonates. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Family Involvement/Empowerment, Family-centered Care, Intensive Care Units, Neonatal
- What is being tested?
- Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates and Standard medical treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,020 participants
- Where
- 2 sitesEthiopia
- Study dates
- 16 Dec 2025to 16 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All neonates aged 0-28 days admitted to level-2 NCUs in the neonatal care unit, including Kangaroo Mother care ward or mothers' side ward, with conditions that require hospital stay at 48 hours; and
- accompanied by at least one parent (preferably a mother) dedicated to spending up to 8 hours per day with the infant
Who cannot join
- Neonates with major congenital anomalies
- Infants with no family member to accompany the infant, or who do not consent to spend up to 8 hours per day in the NCU
- Families with confirmed physical and/or mental problems limiting their capability to communicate and to engage, or those who leave against medical advice
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia2 sites, 2 recruiting
- Recruiting
Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital
Mek'ele, Tigray, 1871
Znabu Hadush Kahsay, MPH, PhD student, 0920874140, hadiszinabu@gmail.com
Araya Abrha Dr.Medhanyie, PhD, +251 933222222, araya.medhanyie@gmail.com
- Not yet recruiting
Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital
Mek'ele, Tigray, 1871
Znabu Hadush Mr. Kahsay, MPH, PhD student, +251-920-874-140, hadiszinabu@gmail.com
About this study
Official title: Effectiveness of Implementing Family-Integrated Newborn Care to Improve Outcomes for Preterm and Low-birth-weight Neonates in Resource-limited Settings; Quasi-experimental Design
The goal of this quasi-experimental study is to learn if integrating family in newborn care units as a key partner can improve the outcomes of preterm and low-birth-weight neonates. The main question[s] that the study aims to answer:
- Does the implementation of the FINC intervention impact the neonatal outcomes for preterm and low-birth weight neonates in NCUs in resource-limited settings of Tigray, Northern Ethiopia? Researchers will compare the Length of hospital stay among preterm and low-birth-weight neonates admitted to hospitals included in the intervention groups and compared to the neonates admitted to hospitals in the control group.
In the intervention groups, family of preterm and low-birth-weight neonates will be trained, mentored, and integrated into the care targeted to their neonates.
Read the detailed description
The World Health Organization recommends Family involvement and support in the management of preterm and low birth weight neonates. However, the body of literature on its effectiveness in low-resource settings is scanty. The current study aimed to investigate the effectiveness of implementing Family-Integrated Newborn Care to improve outcomes for preterm and low-birth weight Neonates in resource-limited settings in resource-limited settings of Ethiopia. A quasi-experimental design with non-equivalent comparison groups will be employed among 1020 family-neonate dyads in three hospitals with level-2 Neonatal Care Units. The intervention package will mainly consist of training and education sessions for health care providers and families supplemented by measures to ensure infection prevention in level-2 neonatal care units. The effect size of implementing Family-Integrated Newborn Care on neonatal and parental outcomes will be estimated using General Linear Models (GLM) and compared with the conventional care. Research questions are:
- Does the implementation of the FINC intervention impact the neonatal outcomes for preterm and low-birth-weight neonates in NCUs in resource-limited settings of Tigray, Northern Ethiopia?
- Was the uptake of implementation of the FINC intervention for preterm and low-birth-weight neonates acceptable?
- Conditions
- Family Involvement/Empowerment, Family-centered Care, Intensive Care Units, Neonatal, Family Integrated Newborn Care
- Being tested
- Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates, Standard medical treatment
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonatesBehavioural
Also called Family-Centered care, Family Involvement
The Family Integrated Newborn Care intervention includes undergoing 1) minor modifications in the NCU space and physical infrastructure conducive to family integration; 2) bedside training for families, and 3) provision of ten audio-visual materials in the local language (Tigrigna) demonstrating family integration in key caring activities targeted to their neonates.
Standard medical treatmentBehavioural
Also called Conventional newborn care
The preterm and low-birth weight neonates will receive the conventional care with no special attention to integrate the families in the care targeted to the neonates
| Study group | Role | What they receive |
|---|---|---|
| FINC arm | Experimental | This arm includes the family of the neonates assigned to the experimental group, and they will receive a FINC intervention. The FINC intervention, families of preterm and low-birth weight neonates aged 0-28 days will be trained, educated, and encouraged to get involved in the newborn care targeted to their neonates. Receives: Behavioral: Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates |
| Non-FINC arm | Active comparator | This arm includes the families of the neonates assigned to the comparator group, who will receive conventional or standard care. No special effort that the routine care will be provided to integrate the family into the care targeted to the preterm and low-birth-weight neonates Receives: Behavioral: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
It refers to the duration a neonate stays in the hospital for care, starting from admission to discharge home
Measured: The period from the date of admission to the date of discharge is within the first 28 days of neonat's life.
Secondary outcomes (7)
Survival at discharge
Survival status of the neonate at discharge, specified as alive, dead, or referred for higher-level care, or left against medical advice.
Measured: Starting from date of admission to the date of discharge within the first 28 days of the neonate's life
Daily weight gain
The net weight gain of a neonate each day (in grams/kg/day) in reference to the expected gain for the body mass
Measured: Starting from the date of admission up to the date of discharge and assessed in the first 28 days of the neonate's life
Time to initiate breastfeeding after admission
The time the breastfeeding of the neonate is initiated for the first time since admission
Measured: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
Time to initiate skin-to-skin after admission
The first time skin-to-skin is initiated for the neonate, since the date of admission to the Neonatal Intensive Care Unit (NICU)
Measured: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
The number of days on Antibiotics
The total number of days the neonate received antibiotics for being suspected or diagnosed with sepsis
Measured: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
Score for parental stress monitoring scale
A score for the parental stress monitoring scale, which consists of eight items in a five-point Likert scale, with scores ranging from a lower score (1= Not stressful at all) to a higher score (5= Extremely stressful).
Measured: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
Discharge readiness score on the day of the discharge
The score for the discharge readiness scale, consisting of eight items in a five-point Likert scale, to assess parents' readiness at the time of discharge. The score level ranges from a lower score (1= Extremely low confidence) to a higher score (5= Extremely high confidence).
Measured: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start16 Dec 2025
- Primary completion15 Jun 2026 (estimated)
- Study completion16 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Family Involvement/EmpowermentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laerdal Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Mekelle University, Addis Ababa University
- Responsible party
- Principal investigator, Znabu Hadush Kahsay, University of Stavanger
- Investigators
- Siren Rettedal, MD, PhD, Study chair, 1. Faculty of Health Sciences, University of Stavanger, Stavanger, Norway 2. Department of Simulation-based learning, Stavanger University Hospital, NorwayHege Prof.Ersdal, MD, PhD, Study director, hege.ersdal@safer.netDamen Hailemariam, MD, PhD, Study director, damengoog@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364903
- Sponsor's protocol ID
- LaerdalFoundation
- Acronym
- FINC
- Status last verified
- Jan 2026
- First submitted
- 9 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study is part of a PhD study. The dataset consists of inpatient data will be shared after the manuscript summarizing the key findings of the trial is published. Hence, the dataset will be made available open for the public in June 2027. In addition, the IPD can be shared up on reasonable request form the contact person of the study.
Publications
Kahsay ZH, Medhanyie AA, Mariam DH, Ersdal HL, Rettedal S. Feasibility of implementing family-integrated newborn care for hospitalised preterm and low birthweight infants in newborn care units of Ethiopia: a mixed-methods design. BMJ Open. 2025 Jan 21;15(1):e093377. doi: 10.1136/bmjopen-2024-093377.
PubMed 39842933
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Implementing Family-Integrated Newborn Care to Improve Outcomes for Preterm and Low-birth-weight Neonates in Resource-limited Settings; Quasi-experimental Design
- ClinicalTrials.gov ID
- NCT07364903
- Acronym / sponsor ID
- FINC / LaerdalFoundation
- Conditions
- Family Involvement/Empowerment, Family-centered Care, Intensive Care Units, Neonatal, Family Integrated Newborn Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,020 participants (estimated)
- Lead sponsor
- Laerdal FoundationUniversity, hospital or other
- Collaborators
- Mekelle University, Addis Ababa University
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 16 Jun 2026 (estimated)
- First posted
- 23 Jan 2026 (actual)
- 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.
The goal of this quasi-experimental study is to learn if integrating family in newborn care units as a key partner can improve the outcomes of preterm and low-birth-weight neonates. The main question[s] that the study aims to answer:
- Does the implementation of the FINC intervention impact the neonatal outcomes for preterm and low-birth weight neonates in NCUs in resource-limited settings of Tigray, Northern Ethiopia? Researchers will compare the Length of hospital stay among preterm and low-birth-weight neonates admitted to hospitals included in the intervention groups and compared to the neonates admitted to hospitals in the control group.
In the intervention groups, family of preterm and low-birth-weight neonates will be trained, mentored, and integrated into the care targeted to their neonates.
Detailed description
The World Health Organization recommends Family involvement and support in the management of preterm and low birth weight neonates. However, the body of literature on its effectiveness in low-resource settings is scanty. The current study aimed to investigate the effectiveness of implementing Family-Integrated Newborn Care to improve outcomes for preterm and low-birth weight Neonates in resource-limited settings in resource-limited settings of Ethiopia. A quasi-experimental design with non-equivalent comparison groups will be employed among 1020 family-neonate dyads in three hospitals with level-2 Neonatal Care Units. The intervention package will mainly consist of training and education sessions for health care providers and families supplemented by measures to ensure infection prevention in level-2 neonatal care units. The effect size of implementing Family-Integrated Newborn Care on neonatal and parental outcomes will be estimated using General Linear Models (GLM) and compared with the conventional care. Research questions are:
- Does the implementation of the FINC intervention impact the neonatal outcomes for preterm and low-birth-weight neonates in NCUs in resource-limited settings of Tigray, Northern Ethiopia?
- Was the uptake of implementation of the FINC intervention for preterm and low-birth-weight neonates acceptable?
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FINC arm | Experimental | Behavioral: Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonatesThis arm includes the family of the neonates assigned to the experimental group, and they will receive a FINC intervention. The FINC intervention, families of preterm and low-birth weight neonates aged 0-28 days will be trained, educated, and encouraged to get involved in the newborn care targeted to their neonates. |
| Non-FINC arm | Active comparator | Behavioral: Standard medical treatmentThis arm includes the families of the neonates assigned to the comparator group, who will receive conventional or standard care. No special effort that the routine care will be provided to integrate the family into the care targeted to the preterm and low-birth-weight neonates |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All neonates aged 0-28 days admitted to level-2 NCUs in the neonatal care unit, including Kangaroo Mother care ward or mothers' side ward, with conditions that require hospital stay at 48 hours; and
- accompanied by at least one parent (preferably a mother) dedicated to spending up to 8 hours per day with the infant
Key exclusion criteria (3 listed)
- Neonates with major congenital anomalies
- Infants with no family member to accompany the infant, or who do not consent to spend up to 8 hours per day in the NCU
- Families with confirmed physical and/or mental problems limiting their capability to communicate and to engage, or those who leave against medical advice
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 |
|---|---|---|
| Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonatesAlso: Family-Centered care, Family InvolvementThe Family Integrated Newborn Care intervention includes undergoing 1) minor modifications in the NCU space and physical infrastructure conducive to family integration; 2) bedside training for families, and 3) provision of ten audio-visual materials in the local language (Tigrigna) demonstrating family integration in key caring activities targeted to their neonates. | Behavioural | FINC arm |
| Standard medical treatmentAlso: Conventional newborn careThe preterm and low-birth weight neonates will receive the conventional care with no special attention to integrate the families in the care targeted to the neonates | Behavioural | Non-FINC arm |
Primary outcome
Length of hospital stay
Time frame: The period from the date of admission to the date of discharge is within the first 28 days of neonat's life.
It refers to the duration a neonate stays in the hospital for care, starting from admission to discharge home
7 secondary outcomes
Survival at discharge
Time frame: Starting from date of admission to the date of discharge within the first 28 days of the neonate's life
Daily weight gain
Time frame: Starting from the date of admission up to the date of discharge and assessed in the first 28 days of the neonate's life
Time to initiate breastfeeding after admission
Time frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
Time to initiate skin-to-skin after admission
Time frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
The number of days on Antibiotics
Time frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
Score for parental stress monitoring scale
Time frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
Discharge readiness score on the day of the discharge
Time frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Background: PubMed 39842933Kahsay ZH, Medhanyie AA, Mariam DH, Ersdal HL, Rettedal S. Feasibility of implementing family-integrated newborn care for hospitalised preterm and low birthweight infants in newborn care units of Ethiopia: a mixed-methods design. BMJ Open. 2025 Jan 21;15(1):e093377. doi: 10.1136/bmjopen-2024-093377.
- Individual participant dataSharing planned: Yes. The study is part of a PhD study. The dataset consists of inpatient data will be shared after the manuscript summarizing the key findings of the trial is published. Hence, the dataset will be made available open for the public in June 2027. In addition, the IPD can be shared up on reasonable request form the contact person of the study.
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.
Siren Rettedal, MD, PhD study chair
1. Faculty of Health Sciences, University of Stavanger, Stavanger, Norway 2. Department of Simulation-based learning, Stavanger University Hospital, Norway
Hege Prof.Ersdal, MD, PhD study director
hege.ersdal@safer.net
Damen Hailemariam, MD, PhD study director
damengoog@gmail.com
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates and Standard medical treatment in people with Family Involvement/Empowerment and Family-centered Care, run by Laerdal Foundation at 2 sites in Ethiopia.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ethiopia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Znabu Hadush Mr.Kahsay, MPH, PhD student (+251 1920874140, znabu.hadish@mu.edu.et), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: The period from the date of admission to the date of discharge is within the first 28 days of neonat's life.). 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 NCT07364903, which also lists 1 linked publication.
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 23 Jan 2026.