Newborn CareNCT07535684
Impact of Early Essential Newborn Care (EENC) on Maternal and Neonatal Outcomes in a Tertiary Care Hospital
A study testing Early Essential Newborn Care and Routine Postnatal Care in people with Newborn Care, run by Sheikh Zayed Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Newborn Care
- What is being tested?
- Early Essential Newborn Care and Routine Postnatal Care
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 sitePakistan
- Study dates
- 5 May 2025to 5 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sheikh Zayed Medical college/hospital
Rahim Yar Khan, Punjab Province, 64200
About this study
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
- Being tested
- Early Essential Newborn Care, Routine Postnatal Care
- Keywords
- Early Essential Newborn Care, Skin-to-Skin Contact, Breast Feeding Initiation, Exclusive Breast Feeding, Newborn Infant, Maternal Health
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Essential Newborn CareProcedure or surgery
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 CareProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Routine Postnatal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: assessed within 24 hours postpartum
Secondary outcomes (9)
Early Breastfeeding Initiation
Proportion of newborns who begin breastfeeding within 60 minutes after birth.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 2 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start5 May 2025
- Primary completion5 Oct 2025
- Study completion5 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kainat usman, Sheikh Zayed Medical College
- Investigators
- Natasha Irum, Principal investigator, Sheikh Zayed Medical college/Hospital, Rahimyar Khan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535684
- Sponsor's protocol ID
- Sheikh ZMC/H5
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Essential Newborn Care (EENC) on Maternal and Neonatal Outcomes in a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT07535684
- Acronym / sponsor ID
- Sheikh ZMC/H5
- Conditions
- Newborn Care
- Keywords
- Early Essential Newborn Care, Skin-to-Skin Contact, Breast Feeding Initiation, Exclusive Breast Feeding, Newborn Infant, Maternal Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- 5 May 2025 (actual)
- Primary completion
- 5 Oct 2025 (actual)
- Study completion
- 5 Oct 2025 (actual)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Essential Newborn Care Group | Experimental | Procedure: Early Essential Newborn CareReceived 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. |
| Routine Postnatal Care Group | Active comparator | Procedure: Routine Postnatal CareReceived 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Essential Newborn CareImmediate 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. | Procedure or surgery | Early Essential Newborn Care Group |
| Routine Postnatal CareStandard 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. | Procedure or surgery | Routine Postnatal Care Group |
Primary outcome
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.
9 secondary outcomes
Early Breastfeeding Initiation
Time frame: Within the first 60 minutes after birth
Exclusive Breastfeeding Rate at Day 7
Time frame: From birth to day 7 postpartum
Incidence of Neonatal Hypothermia
Time frame: Within the first 24 hours after birth
Admission to Neonatal Intensive Care Unit
Time frame: Within the first 24 hours after birth
Neonatal Infection
Time frame: Within the first 7 days of life
Postpartum Blood Loss
Time frame: Within the first 24 hours postpartum
Maternal Anxiety Score
Time frame: 120 minutes after delivery
Maternal Pain Score at 30 Minutes
Time frame: 30 minutes after delivery
Maternal Pain Score at 2 Hours
Time frame: 2 hours after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natasha Irum principal investigator
Sheikh Zayed Medical college/Hospital, Rahimyar Khan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Essential Newborn Care and Routine Postnatal Care in people with Newborn Care, run by Sheikh Zayed Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful First Breastfeeding (time frame: assessed within 24 hours postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.