Low Birth Weight Baby(HBEP-LBWC)NCT07482904
Home-based Interventional Program on Low Birth Weight Baby Care
A study testing Home-based Interventional group in people with Low Birth Weight Baby and Very Low Birth Weight Baby, run by Chawarwan Saleem Abdullah at 1 site in Iraq.
Trial summary
The goal of this interventional study is to evaluate whether a home-based interventional program for mothers can improve their knowledge and performance in caring for their low birth weight baby at home. Read more about this study
- Who is it for?
- Ages 1 day to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Low Birth Weight Baby, Very Low Birth Weight Baby
- What is being tested?
- Home-based Interventional group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIraq
- Study dates
- 1 Oct 2024to 25 Oct 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 1 day to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Low birth weight< 2500gram
Who cannot join
- extremely low birth weight (<1000gram).
- Orphan children (mother's die).
- Baby with congenital anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Home-based Interventional Program on Mothers' Performance Concerning Low Birth Weight Baby Care in Erbil City
The goal of this interventional study is to evaluate whether a home-based interventional program for mothers can improve their knowledge and performance in caring for their low birth weight baby at home. The study focus on LBW babies, Particularly [ Low Birth Weight baby who their weight less than 2500g and Very Low Birth Weight babies who their weight less than 1500g], and aims to determine that home based interventional program will improve the health outcome of low birth weight babies.
The main questions it aims to answer are:
- How do home-based intervention programs improve mothers' performance and associated health outcomes in the care of low birth weight (LBW) infants?
- How effective is a home-based intervention program in improving mothers' knowledge regarding low birth weight (LBW) baby care in Erbil during 2025-2026?
Read the detailed description
This interventional study aims to explore the effectiveness of home-based interventional program on mothers' performance concerning low birth weight baby care.In Erbil City, many mothers of LBW infants lack adequate support mechanisms after hospital discharge, leading to suboptimal care practices and infant health outcomes. This study will assess the role of home interventional program on improving mother's knowledge, performance, and enhancing LBW infant health outcome.
The study will involve two groups of mothers with Low Birth weight baby:
Intervention Group: Mothers will receiving structured home-based interventional program regarding thermoregulation, skin to skin contact, breastfeeding, umbilical care, skin care, infection prevention, and recognizing danger signs at home.
Control Group: Mothers will not receiving structured home-based interventional program regarding thermoregulation, skin to skin contact, breastfeeding, umbilical care, skin care, infection prevention, and recognizing danger signs at home.
The home-based interventional program will cover the following...
- Perform home care management regarding thermoregulations
- Know the way of heat loss among newborns
- List the benefits of skin-to-skin contact for mothers and babies.
- Demonstrate skin to skin contact care.
- Explain the benefits of breastfeeding for mothers and babies.
- Apply home care management regarding breastfeeding.
- Model ways of expressing breast milk.
- Practice cup feeding for low birth weight baby at home.
- Illustrate home care management regarding infection prevention.
- Perform home care management regarding skin and umbilical care.
- Describe home care management regarding recognizing danger signs.
Data will collect by the following techniques:
- All mothers (control and intervention groups) will interview for explaining the purpose of the study.
- All mothers in (control and intervention groups) will expose to the pre-test in order to detect the knowledge and performance of mothers.
- All mothers of the (intervention group) will expose to home based interventional program.
- All mothers in (control group) will not expose to home based interventional program.
- All mothers in (control and intervention groups) will expose to post-test, approximately two weeks after the implementation of the program.
- All mothers in (control and intervention groups) will expose to post-test, approximately three months after the implementation of the program.
- Conditions
- Low Birth Weight Baby, Very Low Birth Weight Baby
- Being tested
- Home-based Interventional group
- Keywords
- Low Birth Weight, Home-Based Intervention, Mother Knowledge, Mother Performance, Home care, Thermoregulation, Infection prevention, Erbil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Interventional groupOther
Participants assigned to this intervention arm will be enrolled in a structured, home-based educational program designed to optimize neonatal outcomes through the promotion of evidence-based caregiving practices.
Including
- Prioritizes thermal regulation and prolonged skin-to-skin contact (Kangaroo Mother Care) to mitigate the risks of neonatal hypothermia.
- Provides intensive instruction on exclusive breastfeeding,
- Hygienic umbilical cord and skin maintenance,
- Stringent infection control measures.
A critical component of the intervention involves empowering caregivers with the clinical literacy required for the early recognition of neonatal danger signs, thereby facilitating timely care-seeking behaviors. By transitioning these interventions into the domiciliary environment, the program seeks to bridge the gap between facility-based birth and long-term health stability for Low Birth Weight (LBW) infants.
| Study group | Role | What they receive |
|---|---|---|
| Compare group or Control group | No intervention | in this group it only doing routine cares, this includes any customary facility-based counseling provided at the time of birth or during scheduled follow-up visits. |
| Home- based interventional group | Experimental | Participants assigned to this intervention arm will be enrolled in a structured, home-based educational program designed to optimize neonatal outcomes through the promotion of evidence-based caregiving practices. Receives: Other: Home-based Interventional group |
What is being measured
The primary outcome is the main question the study is designed to answer.
LBW babies health outcome
Primary Outcome:
1-Total weight gain(in grams) from baseline (discharge) to the end of the 2-week and 3 months after home intervention period.
Measured: The 2-weeks and 3 months after home intervention period.
LBW babies health outcome
2-Mean Body Temperature, pulse, and respiratory rate to assess the efficacy of thermal care and Skin-to-Skin contact.
Measured: The 2-weeks and 3 months after home intervention period.
Secondary outcomes (1)
Improvement in mothers' knowledge and performance
Secondary Outcome
- Maternal Knowledge Unit of Measure: Score on a scale of 0 to 75 (Higher scores indicate higher levels of knowledge). Outcome Measure
- Maternal Performance Unit of Measure: 0-75%(Higher scores indicate better adherence to neonatal car
Measured: 2 week after home-based interventional program and 3 months after home-based interventional program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Oct 2024
- Primary completion1 Jan 2026
- Study completion25 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Birth Weight BabyStudies 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
- Single group
- Model description
- Mothers in this group will receive a structured home-based educational program focusing on Low Birth Weight (LBW) care.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chawarwan Saleem Abdullah
- Sponsor type
- University, hospital or other
- Collaborators
- Hawler Medical University
- Responsible party
- Sponsor-investigator, Chawarwan Saleem Abdullah, Hawler Medical University
- Investigators
- Hawler Medical Unversity College of Nursing, Study chair, Hawler Medical university/College of Nursing, Erbil, Kurdistant Region, Iraq, 44001
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482904
- Sponsor's protocol ID
- HawlerMUErbil\Iraq
- Acronym
- (HBEP-LBWC)
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: because I am a Phd student, it is special for me.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Home-based Interventional Program on Mothers' Performance Concerning Low Birth Weight Baby Care in Erbil City
- ClinicalTrials.gov ID
- NCT07482904
- Acronym / sponsor ID
- (HBEP-LBWC) / HawlerMUErbil\Iraq
- Conditions
- Low Birth Weight Baby, Very Low Birth Weight Baby
- Keywords
- Low Birth Weight, Home-Based Intervention, Mother Knowledge, Mother Performance, Home care, Thermoregulation, Infection prevention, Erbil
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Chawarwan Saleem AbdullahUniversity, hospital or other
- Collaborators
- Hawler Medical University
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 25 Oct 2026 (estimated)
- First posted
- 19 Mar 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 interventional study is to evaluate whether a home-based interventional program for mothers can improve their knowledge and performance in caring for their low birth weight baby at home. The study focus on LBW babies, Particularly [ Low Birth Weight baby who their weight less than 2500g and Very Low Birth Weight babies who their weight less than 1500g], and aims to determine that home based interventional program will improve the health outcome of low birth weight babies.
The main questions it aims to answer are:
- How do home-based intervention programs improve mothers' performance and associated health outcomes in the care of low birth weight (LBW) infants?
- How effective is a home-based intervention program in improving mothers' knowledge regarding low birth weight (LBW) baby care in Erbil during 2025-2026?
Detailed description
This interventional study aims to explore the effectiveness of home-based interventional program on mothers' performance concerning low birth weight baby care.In Erbil City, many mothers of LBW infants lack adequate support mechanisms after hospital discharge, leading to suboptimal care practices and infant health outcomes. This study will assess the role of home interventional program on improving mother's knowledge, performance, and enhancing LBW infant health outcome.
The study will involve two groups of mothers with Low Birth weight baby:
Intervention Group: Mothers will receiving structured home-based interventional program regarding thermoregulation, skin to skin contact, breastfeeding, umbilical care, skin care, infection prevention, and recognizing danger signs at home.
Control Group: Mothers will not receiving structured home-based interventional program regarding thermoregulation, skin to skin contact, breastfeeding, umbilical care, skin care, infection prevention, and recognizing danger signs at home.
The home-based interventional program will cover the following...
- Perform home care management regarding thermoregulations
- Know the way of heat loss among newborns
- List the benefits of skin-to-skin contact for mothers and babies.
- Demonstrate skin to skin contact care.
- Explain the benefits of breastfeeding for mothers and babies.
- Apply home care management regarding breastfeeding.
- Model ways of expressing breast milk.
- Practice cup feeding for low birth weight baby at home.
- Illustrate home care management regarding infection prevention.
- Perform home care management regarding skin and umbilical care.
- Describe home care management regarding recognizing danger signs.
Data will collect by the following techniques:
- All mothers (control and intervention groups) will interview for explaining the purpose of the study.
- All mothers in (control and intervention groups) will expose to the pre-test in order to detect the knowledge and performance of mothers.
- All mothers of the (intervention group) will expose to home based interventional program.
- All mothers in (control group) will not expose to home based interventional program.
- All mothers in (control and intervention groups) will expose to post-test, approximately two weeks after the implementation of the program.
- All mothers in (control and intervention groups) will expose to post-test, approximately three months after the implementation of the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mothers in this group will receive a structured home-based educational program focusing on Low Birth Weight (LBW) care.
| Arm | Type | Receives |
|---|---|---|
| Compare group or Control group | No intervention | –in this group it only doing routine cares, this includes any customary facility-based counseling provided at the time of birth or during scheduled follow-up visits. |
| Home- based interventional group | Experimental | Other: Home-based Interventional groupParticipants assigned to this intervention arm will be enrolled in a structured, home-based educational program designed to optimize neonatal outcomes through the promotion of evidence-based caregiving practices. |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Low birth weight< 2500gram
Key exclusion criteria (3 listed)
- extremely low birth weight (<1000gram).
- Orphan children (mother's die).
- Baby with congenital anomalies.
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 |
|---|---|---|
| Home-based Interventional groupParticipants assigned to this intervention arm will be enrolled in a structured, home-based educational program designed to optimize neonatal outcomes through the promotion of evidence-based caregiving practices. Including 1. Prioritizes thermal regulation and prolonged skin-to-skin contact (Kangaroo Mother Care) to mitigate the risks of neonatal hypothermia. 2. Provides intensive instruction on exclusive breastfeeding, 3. Hygienic umbilical cord and skin maintenance, 4. Stringent infection control measures. A critical component of the intervention involves empowering caregivers with the clinical literacy required for the early recognition of neonatal danger signs, thereby facilitating timely care-seeking behaviors. By transitioning these interventions into the domiciliary environment, the program seeks to bridge the gap between facility-based birth and long-term health stability for Low Birth Weight (LBW) infants. | Other | Home- based interventional group |
Primary outcome
LBW babies health outcome
Time frame: The 2-weeks and 3 months after home intervention period.
Primary Outcome: 1-Total weight gain(in grams) from baseline (discharge) to the end of the 2-week and 3 months after home intervention period.
LBW babies health outcome
Time frame: The 2-weeks and 3 months after home intervention period.
2-Mean Body Temperature, pulse, and respiratory rate to assess the efficacy of thermal care and Skin-to-Skin contact.
1 secondary outcome
Improvement in mothers' knowledge and performance
Time frame: 2 week after home-based interventional program and 3 months after home-based interventional program.
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 19 Mar 2026.
- Individual participant dataSharing planned: No. because I am a Phd student, it is special for me.
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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.
Hawler Medical Unversity College of Nursing study chair
Hawler Medical university/College of Nursing, Erbil, Kurdistant Region, Iraq, 44001
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Interventional group in people with Low Birth Weight Baby and Very Low Birth Weight Baby, run by Chawarwan Saleem Abdullah at 1 site in Iraq.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. 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 Iraq. 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?
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?
LBW babies health outcome (time frame: The 2-weeks and 3 months after home intervention period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2026.