Early feeding and kangaroo mother care to prevent infections in premature babies: a pilot study

ISRCTN	ISRCTN47370972
DOI	https://doi.org/10.1186/ISRCTN47370972
Sponsor	Bacha Khan Medical Complex MTI Swabi
Funder	Bacha Khan Medical Complex MTI Swabi

Submission date: 09/12/2025
Registration date: 24/12/2025
Last edited: 19/12/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Waqar Ahmad
Principal investigator, Public, Scientific

Village Dagai, PO Lundkhwar, Tehsil Takhtbhai
Mardan
23200
Pakistan

Phone	+92 (0)3469329420
Email	waqar4244@gmail.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Health services research, Prevention, Supportive care
Scientific title	Early exclusive enteral feeding with mother-incubator care to reduce neonatal sepsis in preterm infants: a randomized controlled pilot trial
Study objectives	Primary objective: 1. To assess whether early exclusive enteral feeding and maternal-incubator care reduces the incidence of neonatal sepsis in clinically stable preterm infants. Secondary objectives: 1. To evaluate time to full enteral feeding 2. To assess weight gain on daily basis and duration of hospital stay 3. To measure maternal satisfaction and feasibility of total enteral feed and bedside care 4. To assess whether our study is cost effective
Ethics approval(s)	Approved 19/12/2025, Gajju Khan Medical College Swabi IREB (Shahmansoor, Shah Mansur, -, Pakistan; -; ireb@gkmcs.edu.pk), ref: IREB/GKMCS/082512450
Health condition(s) or problem(s) studied	Early neonatal sepsis in preterm infants
Intervention	Intervention Group (Early EBM + Maternal-Incubator Care): 1. Initiate total nasogastric feeding with EBM within 3 hours of birth (60–80 mL/kg/day) 2. No IV fluids or antibiotics unless clinically indicated 3. Baby kept in incubator or warmer at mother’s bedside 4. Encourage skin-to-skin contact and enable maternal access for feeding and milk expression 5. Oxygen via nasal cannula if needed 6. Blood sampling and culture on Day 3 of life 7. Terminate protocol if clinical deterioration or feeding intolerance occurs Control Group (Standard NICU Care): 1. Standard NICU care will be provided in accordance with established guidelines (Start et al., 2023) 2. Admission to NICU with IV fluids and oxygen 3. Gradual feeding advancement with EBM 4. Routine investigations after 24 hours and as needed 5. Shift to KMC once baby is stable, on full feeds, and off oxygen
Intervention type	Other
Primary outcome measure(s)	Incidence of culture-positive or clinically diagnosed neonatal sepsis measured using Clinical signs (oxygen requirements, apnea, respiratory rate, heart rate, temperature instability, feeding intolerance) and Laboratory results (WBC, platelet count) at within the first 7 days
Key secondary outcome measure(s)	Measured using patient records at end of stay: 1. Time to achieve full enteral feeding 2. Weight gain at discharge 3. Duration of hospital stay 4. Maternal satisfaction (via structured questionnaire) 5. Cost-effectiveness in terms of hospital stay, antibiotics use, incubator and NICU charges
Completion date	31/03/2026

Eligibility

Participant type(s)
Age group	Neonate
Lower age limit	0 Days
Upper age limit	1 Day
Sex	All
Target sample size at registration	30
Total final enrolment	100
Key inclusion criteria	1. Gestational age >30 and <37 weeks 2. Birth weight >1000 g 3. Clinically stable at birth: Apgar ≥7 at 5 minutes or no need for invasive ventilation 4. Minimal respiratory support allowed: room air or oxygen ≤2 L/min via nasal cannula 5. No major congenital anomalies 6. Mother is stable and can take care for newborn
Key exclusion criteria	1. Need for immediate resuscitation or mechanical ventilation 2. Clinical signs of sepsis at birth (e.g., temperature instability, poor perfusion, metabolic acidosis) 3. Prolonged rupture of membranes >18 hours with maternal chorioamnionitis or other high-risk infections 4. Maternal fever >38°C during labor or proven maternal sepsis 5. Major surgical conditions or gastrointestinal malformations 6. Reverse diastolic flow on prenatal ultrasound 7. Maternal death
Date of first enrolment	17/10/2025
Date of final enrolment	31/03/2026

Locations

Countries of recruitment

Pakistan

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

19/12/2025: Trial's existence confirmed by Gajju Khan Medical College Swabi IREB.