Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07482904

Home-based Interventional Program on Low Birth Weight Baby Care

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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Low Birth Weight Baby Very Low Birth Weight Baby

Age range

1 day–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hawler Medical Unversity

Erbil, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Low birth weight< 2500gram

Exclusion criteria

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

Treatment and study plan

Home-based Interventional group

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

    • 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

Sponsors and collaborators

Lead sponsor

Chawarwan Saleem Abdullah

Other

Collaborators

  • Hawler Medical University

Registry information

Official study title

Effectiveness of Home-based Interventional Program on Mothers' Performance Concerning Low Birth Weight Baby Care in Erbil City

Acronym: (HBEP-LBWC)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.