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Completed

NCT Number: NCT07535684

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.

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Key information

Conditions

Newborn Care Behavior Breast Feeding Feeding Behavior

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sheikh Zayed Medical college/hospital

Rahim Yar Khan, Punjab Province, 64200, Pakistan

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Successful First Breastfeeding

    Time frame: assessed within 24 hours postpartum

    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.

Secondary outcomes

  1. Early Breastfeeding Initiation

    Time frame: Within the first 60 minutes after birth

    Proportion of newborns who begin breastfeeding within 60 minutes after birth.

  2. Exclusive Breastfeeding Rate at Day 7

    Time frame: From birth to day 7 postpartum

    Proportion of infants receiving only breast milk, with no supplementary liquids or solid foods, from birth up to 7 days postpartum.

  3. Incidence of Neonatal Hypothermia

    Time frame: Within the first 24 hours after birth

    Proportion of newborns with axillary temperature below 36.0°C at any time during the first 24 hours of life.

  4. Admission to Neonatal Intensive Care Unit

    Time frame: Within the first 24 hours after birth

    Proportion of newborns admitted to the Neonatal Intensive Care Unit for any clinical indication.

  5. Neonatal Infection

    Time frame: Within the first 7 days of life

    Proportion of newborns with neonatal infection defined by both clinical signs or symptoms suggestive of infection and microbiological confirmation by positive blood culture.

  6. Postpartum Blood Loss

    Time frame: Within the first 24 hours postpartum

    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.

  7. Maternal Anxiety Score

    Time frame: 120 minutes after delivery

    Maternal anxiety assessed using the State-Trait Anxiety Inventory-State, with total score ranging from 20 to 80. Higher scores indicate greater anxiety.

  8. Maternal Pain Score at 30 Minutes

    Time frame: 30 minutes after delivery

    Maternal pain intensity measured using the Visual Analog Scale, ranging from 0 to 10, with higher scores indicating greater pain

  9. Maternal Pain Score at 2 Hours

    Time frame: 2 hours after delivery

    Maternal pain intensity measured using the Visual Analog Scale, ranging from 0 to 10, with higher scores indicating greater pain.

Sponsors and collaborators

Lead sponsor

Sheikh Zayed Medical College

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2026
Registry last updated
Apr 17, 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.

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