Impact of Early Essential Newborn Care (EENC) on Maternal and Neonatal Outcomes in a Tertiary Care Hospital

This study was examine whether Early Essential Newborn Care (EENC), a simple package of care given immediately after birth, could improve the health of both mothers and newborns compared with the routine care currently provided in the hospital. EENC included drying the baby right after birth, placing the baby in direct skin-to-skin contact with the mother, delaying cord clamping until pulsations stop, keeping the baby warm, and helping breastfeeding start within the first hour. In the routine care group, babies were received the usual hospital care, which may include early cord clamping, placement under a radiant warmer, and later skin-to-skin contact and breastfeeding.

A total of 162 mother-baby pairs were enrolled at Shaikh Zayed Hospital, Rahim Yar Khan, and randomly assigned to either the EENC group or the routine care group. The study was included women aged 18 to 40 years with singleton term pregnancies who deliver vaginally, and whose babies are expected to weigh at least 2500 grams. Mothers with serious medical or obstetric problems, and newborns with major abnormalities or medical conditions, were not included.

The study was compared important newborn outcomes such as early breastfeeding, time to first breastfeeding, exclusive breastfeeding up to 7 days, low body temperature, low blood sugar in at-risk babies, admission to the neonatal intensive care unit, eye infection, and confirmed infection during the first week of life. Maternal outcomes such as the duration of the third stage of labor, blood loss after delivery, pain, and anxiety were also measured.

Study Overview

• Status: Completed
• Conditions: Newborn Care
• Intervention / Treatment: Procedure: Early Essential Newborn Care; Procedure: Routine Postnatal Care

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Rahim Yar Khan, Punjab Province, Pakistan, 64200
      • Sheikh Zayed Medical college/hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female age ≥ 18 to 40 years.
• Gestational age between 37 and 41+6 weeks at the time of delivery.
• Singleton pregnancies confirmed by antenatal assessment.
• Estimated fetal birth weight of 2500 grams or more, based on obstetric ultrasonography.
• Mothers intending to remain admitted in the hospital for a minimum of 24 hours following delivery.
• Delivery must be completed via the vaginal route.

Exclusion Criteria:

• Women who undergo emergency cesarean section.
• Neonates presenting with congenital deformities.
• Newborns with structural anomalies or medical conditions.
• Mothers experiencing severe obstetric complications or having significant underlying medical illnesses.
• Mothers with contraindications to breastfeeding due to medical conditions (e.g., HIV infection, syphilis, prior breast surgeries, mastitis, or breast abscess).
• Women who decline or are unable to provide informed consent.
• Mother-infant dyads transferred to another healthcare facility within 24 hours postpartum.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Essential Newborn Care Group; Received Early Essential Newborn Care immediately after vaginal birth, including immediate drying, uninterrupted skin-to-skin contact, delayed cord clamping, thermal protection, and breastfeeding initiation within the first hour.	Procedure: Early Essential Newborn Care; Immediate drying within 5 seconds after birth, skin-to-skin contact within the first minute for at least 90 minutes, delayed cord clamping after pulsations cease, thermal protection with wrapping and head covering, and initiation of breastfeeding within the first hour. Routine postnatal care will follow after the initial EENC period.
Active Comparator: Routine Postnatal Care Group; Received standard hospital postnatal care, including immediate drying, radiant warmer care, prompt cord clamping, routine newborn care, and later skin-to-skin contact and breastfeeding according to usual practice.	Procedure: Routine Postnatal Care; Standard labor room care including immediate drying, placement under a radiant warmer for about 20 minutes, prompt cord clamping, birth measurements, routine immunization, later skin-to-skin contact after the third stage of labor, and subsequent breastfeeding initiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful First Breastfeeding	Proportion of newborns with successful first breastfeeding, defined as an Infant Breastfeeding Assessment Tool score of 10 or more out of 12 during the first breastfeeding session after birth.	assessed within 24 hours postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Breastfeeding Initiation	Proportion of newborns who begin breastfeeding within 60 minutes after birth.	Within the first 60 minutes after birth
Exclusive Breastfeeding Rate at Day 7	Proportion of infants receiving only breast milk, with no supplementary liquids or solid foods, from birth up to 7 days postpartum.	From birth to day 7 postpartum
Incidence of Neonatal Hypothermia	Proportion of newborns with axillary temperature below 36.0°C at any time during the first 24 hours of life.	Within the first 24 hours after birth
Admission to Neonatal Intensive Care Unit	Proportion of newborns admitted to the Neonatal Intensive Care Unit for any clinical indication.	Within the first 24 hours after birth
Neonatal Infection	Proportion of newborns with neonatal infection defined by both clinical signs or symptoms suggestive of infection and microbiological confirmation by positive blood culture.	Within the first 7 days of life
Postpartum Blood Loss	Amount of maternal blood loss in milliliters during the first 24 hours postpartum, measured by pad-weighing method, with 1 gram weight difference considered equal to 1 milliliter blood loss.	Within the first 24 hours postpartum
Maternal Anxiety Score	Maternal anxiety assessed using the State-Trait Anxiety Inventory-State, with total score ranging from 20 to 80. Higher scores indicate greater anxiety.	120 minutes after delivery
Maternal Pain Score at 30 Minutes	Maternal pain intensity measured using the Visual Analog Scale, ranging from 0 to 10, with higher scores indicating greater pain	30 minutes after delivery
Maternal Pain Score at 2 Hours	Maternal pain intensity measured using the Visual Analog Scale, ranging from 0 to 10, with higher scores indicating greater pain.	2 hours after delivery

Collaborators and Investigators

• Sponsor: Sheikh Zayed Medical College
• Investigators: Principal Investigator: Natasha Irum, Sheikh Zayed Medical college/Hospital, Rahimyar Khan

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2025
• Primary Completion (Actual): October 5, 2025
• Study Completion (Actual): October 5, 2025

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Maternal Health; Newborn Infant; Skin-to-Skin Contact; Early Essential Newborn Care; Breast Feeding Initiation; Exclusive Breast Feeding
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding
• Other Study ID Numbers: Sheikh ZMC/H5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No