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

NCT07535684 | Completed

• 1 other identifier: Sheikh ZMC/H5
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Newborn Care

Keywords

Early Essential Newborn Care; Skin-to-Skin Contact; Breast Feeding Initiation; Exclusive Breast Feeding; Newborn Infant; Maternal Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Early Breastfeeding Initiation

  Within the first 60 minutes after birth

• Exclusive Breastfeeding Rate at Day 7

  From birth to day 7 postpartum

• Incidence of Neonatal Hypothermia

  Within the first 24 hours after birth

• Admission to Neonatal Intensive Care Unit

  Within the first 24 hours after birth

• Neonatal Infection

  Within the first 7 days of life

Study Arms (2)

Early Essential Newborn Care Group

EXPERIMENTAL

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

Routine Postnatal Care Group

ACTIVE COMPARATOR

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

Interventions

Early Essential Newborn Care PROCEDURE

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.

Early Essential Newborn Care Group

Routine Postnatal Care PROCEDURE

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.

Routine Postnatal Care Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant Females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheikh Zayed Medical College: lead

Study Sites (1)

Sheikh Zayed Medical college/hospital

Rahim Yar Khan, Punjab Province, 64200, Pakistan

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Natasha Irum

  Sheikh Zayed Medical college/Hospital, Rahimyar Khan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 17, 2026
• Study Start: May 5, 2025
• Primary Completion: October 5, 2025
• Study Completion: October 5, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

PA (1)