Home-based Interventional Program on Low Birth Weight Baby Care ((HBEP-LBWC))

March 14, 2026 updated by: Chawarwan Saleem Abdullah

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:

  1. How do home-based intervention programs improve mothers' performance and associated health outcomes in the care of low birth weight (LBW) infants?
  2. How effective is a home-based intervention program in improving mothers' knowledge regarding low birth weight (LBW) baby care in Erbil during 2025-2026?

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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:

  1. All mothers (control and intervention groups) will interview for explaining the purpose of the study.
  2. All mothers in (control and intervention groups) will expose to the pre-test in order to detect the knowledge and performance of mothers.
  3. All mothers of the (intervention group) will expose to home based interventional program.
  4. All mothers in (control group) will not expose to home based interventional program.
  5. All mothers in (control and intervention groups) will expose to post-test, approximately two weeks after the implementation of the program.
  6. All mothers in (control and intervention groups) will expose to post-test, approximately three months after the implementation of the program.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Erbil, Iraq
        • Hawler Medical Unversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

1. Low birth weight< 2500gram

Exclusion Criteria:

  1. extremely low birth weight (<1000gram).
  2. Orphan children (mother's die).
  3. Baby with congenital anomalies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Compare group or Control group
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.
Experimental: Home- based interventional group
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.
Other: Home-based Interventional group

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

  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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The 2-weeks 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.
The 2-weeks and 3 months after home intervention period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in mothers' knowledge and performance
Time Frame: 2 week after home-based interventional program and 3 months after home-based interventional program.

Secondary Outcome

  1. Maternal Knowledge Unit of Measure: Score on a scale of 0 to 75 (Higher scores indicate higher levels of knowledge).

    Outcome Measure

  2. Maternal Performance Unit of Measure: 0-75%(Higher scores indicate better adherence to neonatal car
2 week after home-based interventional program and 3 months after home-based interventional program.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chawarwan Saleem Abdullah

Collaborators

Hawler Medical University

Investigators

  • Study Chair: Hawler Medical Unversity College of Nursing, Hawler Medical university/College of Nursing, Erbil, Kurdistant Region, Iraq, 44001

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

January 1, 2026

Study Completion (Estimated)

October 25, 2026

Study Registration Dates

First Submitted

March 7, 2026

First Submitted That Met QC Criteria

March 14, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 14, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HawlerMUErbil\Iraq

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

because I am a Phd student, it is special for me.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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