Newborn Care
Conditions
Keywords
Early Essential Newborn Care, Skin-to-Skin Contact, Breast Feeding Initiation, Exclusive Breast Feeding, Newborn Infant, Maternal Health
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.
Interventions
PROCEDUREEarly 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.
PROCEDURERoutine 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.
Sponsors
Sheikh Zayed Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful First Breastfeeding | 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
| Measure | Time frame | Description |
|---|---|---|
| Early Breastfeeding Initiation | Within the first 60 minutes after birth | Proportion of newborns who begin breastfeeding within 60 minutes after birth. |
| Exclusive Breastfeeding Rate at Day 7 | 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. |
| Incidence of Neonatal Hypothermia | 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. |
| Admission to Neonatal Intensive Care Unit | Within the first 24 hours after birth | Proportion of newborns admitted to the Neonatal Intensive Care Unit for any clinical indication. |
| Neonatal Infection | 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. |
| Postpartum Blood Loss | 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. |
| Maternal Anxiety Score | 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. |
| Maternal Pain Score at 30 Minutes | 30 minutes after delivery | Maternal pain intensity measured using the Visual Analog Scale, ranging from 0 to 10, with higher scores indicating greater pain |
| Maternal Pain Score at 2 Hours | 2 hours after delivery | Maternal pain intensity measured using the Visual Analog Scale, ranging from 0 to 10, with higher scores indicating greater pain. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORNatasha Irum
Sheikh Zayed Medical college/Hospital, Rahimyar Khan
Outcome results
None listed