Home-based Interventional Program on Low Birth Weight Baby Care

NCT07482904 | Active Not Recruiting DMC

• 1 other identifier: HawlerMUErbil\Iraq
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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. 1.How do home-based intervention programs improve mothers' performance and associated health outcomes in the care of low birth weight (LBW) infants?
2. 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?

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  The 2-weeks and 3 months after home intervention period.

Secondary Outcomes (1)

• Improvement in mothers' knowledge and performance

  2 week after home-based interventional program and 3 months after home-based interventional program.

Study Arms (2)

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.

Other: Home-based Interventional group

Interventions

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 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.

Home- based interventional group

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. Low birth weight\< 2500gram

You may not qualify if:

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

Sponsors & Collaborators

• Chawarwan Saleem Abdullah: lead
• Hawler Medical University: collaborator

Study Sites (1)

Hawler Medical Unversity

Erbil, Iraq

Location

Study Officials

• Hawler Medical Unversity College of Nursing

  Hawler Medical university/College of Nursing, Erbil, Kurdistant Region, Iraq, 44001

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Model Details: Mothers in this group will receive a structured home-based educational program focusing on Low Birth Weight (LBW) care.

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 19, 2026
• Study Start: October 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): October 25, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)