Neonatal HypoglycemiaNCT06543160
Immediate Skin-To-Skin Contact and Early Breastfeeding During Caesarean Section
A study testing Immediate SSC and early breastfeeding during CS, Delayed SSC and breastfeeding after CS and Routine newborn care in people with Neonatal Hypoglycemia, run by Qingdao Municipal Hospital at 1 site in China.
Trial summary
Background: Neonatal hypoglycemia is a prevalent and serious condition among late preterm and term infants, which can lead to severe neurodevelopmental consequences if not managed properly. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neonatal Hypoglycemia
- What is being tested?
- Immediate SSC and early breastfeeding during CS, Delayed SSC and breastfeeding after CS and Routine newborn care
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 20 Jul 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- mothers aged 18 years or older with a singleton pregnancy, gestational age between 34+1 and 41+6 weeks.
- undergoing elective cesarean section with epidural, subarachnoid block, or combined spinal-epidural anesthesia, willing to engage in mother-infant SSC during and after the surgery, without experiencing severe reactions to anesthesia like vomiting or shivering that could affect SSC.
- having intention to breastfeed with no major contraindications (e.g., hepatitis B, syphilis, HIV, or other infectious diseases).
- newborns with Apgar scores above 8 at 1 and 5 minutes, a strong sucking reflex, and no critical neonatal conditions requiring transfer.
Who cannot join
- serious pregnancy complications such as placenta previa, placenta accreta spectrum, eclampsia, and grade 3 or higher cardiac issues per NYHA standards.
- challenges in initiating mother-infant SSC include emergencies such as neonatal asphyxia or respiratory distress, maternal excessive bleeding during surgery, and maternal infectious dermatoses.
- previous breast surgeries such as biopsies or augmentations, nipple inversions complicating breastfeeding, or taking medications affecting lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Skin-to-Skin Contact and Breastfeeding During Caesarean Section: A Randomized Controlled Trial on Early Neonatal Hypoglycemia in Late Preterm and Term Infants
Background: Neonatal hypoglycemia is a prevalent and serious condition among late preterm and term infants, which can lead to severe neurodevelopmental consequences if not managed properly. Immediate skin-to-skin contact (SSC) and early initiation of breastfeeding are recognized as effective interventions to stabilize glucose levels and support neonatal adaptation to extrauterine life. However, implementing these practices during cesarean sections (CS) presents challenges due to the need to maintain a sterile surgical environment and logistical complexities.
Objective: This study aims to evaluate the effects of immediate SSC and early breastfeeding initiation during CS on neonatal hypoglycemia and breastfeeding outcomes.
Methods: A randomized controlled trial was conducted with 336 mother-neonate pairs undergoing elective CS. Participants were randomly assigned to either the experimental group, which received immediate SSC and early breastfeeding during CS, or the control group, which received standard care. Blood glucose levels of neonates were monitored at 1, 3, and 6 hours post-birth. Additional outcomes included the time to breastfeeding initiation, duration of the first breastfeeding session, onset of lactogenesis II, and the rate of exclusive breastfeeding during hospitalization.
Read the detailed description
Neonatal hypoglycemia is a common condition among late preterm and term infants. It can lead to severe neurodevelopmental consequences if not managed properly. Immediate skin-to-skin contact (SSC) and early initiation of breastfeeding are effective interventions for stabilizing glucose levels and supporting neonatal adaptation to extrauterine life. While these practices are well-documented for their benefits in vaginal births, their implementation during cesarean sections (CS) presents challenges due to the need for maintaining a sterile surgical environment and the logistical complexities involved. The primary objective of this study was to evaluate the effects of immediate SSC and early breastfeeding initiation during CS on neonatal hypoglycemia and breastfeeding outcomes in late preterm and term infants.
This study was designed as a pragmatic, parallel-design, two-arm randomized controlled trial. It was conducted at Qingdao Municipal Hospital in China from July 2023 to July 2024. A total of 336 eligible mother-neonate pairs undergoing elective CS were included in the study.
Participants included mothers aged 18 years or older with a singleton pregnancy and gestational age between 34+1 and 41+6 weeks, undergoing elective CS with epidural or spinal anesthesia, willing to engage in SSC and breastfeeding during and after surgery, and newborns with Apgar scores above 8 at 1 and 5 minutes, a strong sucking reflex, and no critical conditions requiring transfer. Exclusion criteria involved serious pregnancy complications (e.g., placenta previa, eclampsia), conditions hindering SSC initiation (e.g., neonatal asphyxia, maternal excessive bleeding), and previous breast surgeries or medications affecting breastfeeding.
Participants were randomly assigned to either the experimental group (immediate SSC and early breastfeeding during CS) or the control group (standard care) using a block randomization sequence generated by Microsoft Excel 2010. The randomization process was centrally managed, with blinding maintained for staff performing SSC and data collectors, though patient blinding was not feasible.
Interventions:
Experimental Group:
- SSC and Breastfeeding During CS: Immediately after delivery, the surgical drape was lowered for parents to witness the birth. The neonate was placed prone on the mother's chest and dried within 20-30 seconds. Breastfeeding was initiated as soon as possible, and SSC continued throughout the surgery and for at least 90 minutes post-transfer to the ward.
- Routine Newborn Care: Included standard newborn care such as eye care, vitamin K1 administration, immunizations, and weighing, conducted before transferring the neonate to the ward.
Control Group:
- Delayed SSC and Breastfeeding: SSC was initiated within one hour after birth and maintained for at least 90 minutes post-surgery. The neonate was dried within 20-30 seconds after birth and sent to the ward while the mother completed the surgery.
- Routine Newborn Care: Similar to the experimental group.
Outcome Measures:
Primary Outcome: Incidence of neonatal hypoglycemia, with blood glucose levels monitored at 1, 3, and 6 hours post-birth using the Stat Strip Xpress glucose meter. Hypoglycemia was categorized as mild (<45 mg/dL), moderate-to-severe (<36 mg/dL), and severe (<18 mg/dL).
Secondary Outcomes: Included time to breastfeeding initiation, duration of the first breastfeeding session, onset of lactogenesis II (significant milk secretion perceived by the mother), and rate of exclusive breastfeeding during hospitalization.
- Conditions
- Neonatal Hypoglycemia
- Being tested
- Immediate SSC and early breastfeeding during CS, Delayed SSC and breastfeeding after CS, Routine newborn care
- Keywords
- neonatal hypoglycemia, skin-to-skin contact, breastfeeding, cesarean section, lactogenesis
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate SSC and early breastfeeding during CSOther
Upon birth, the neonate is promptly placed prone on the mother's chest, with their head turned to one side for optimal skin contact. The drying process begins within 5 seconds and is completed within 20 to 30 seconds while the neonate remains on the mother's chest. Delayed cord clamping is practiced, with the cord clamped approximately 1-3 minutes after birth. Breastfeeding cues such as tongue movements or head turning are monitored, and the obstetric nurse assists the mother in initiating breastfeeding as soon as possible. SSC continues throughout the cesarean procedure, and upon completion, the newborn is temporarily separated from the mother for safety during transfer to the surgical cart. SSC is resumed immediately post-transfer and continues for a cumulative duration of at least 90 minutes. The neonate's skin color, breathing, and feeding responses are continuously observed.
Delayed SSC and breastfeeding after CSOther
The neonate is dried within 20-30 seconds after birth, the cord is clamped after 1-3 minutes, and then the neonate is sent to the ward to wait for the mother to complete the surgery. Immediate SSC is initiated within one hour after birth and maintained with the mother for at least 90 minutes post-surgery, during which the neonate's skin color and breathing are continuously monitored. The obstetric nurse supports the mother in initiating breastfeeding at the earliest opportunity.
Routine newborn careOther
Newborn eye care, vitamin K1 administration, immunizations, weighing, and standard examinations are conducted before the neonate is transferred to the ward.
| Study group | Role | What they receive |
|---|---|---|
| Immediate SSC and early breastfeeding during CS group | Experimental | Receiving immediate SSC and early breastfeeding during CS and routine newborn care Receives: Other: Immediate SSC and early breastfeeding during CS; Other: Routine newborn care |
| control group | Other | Receiving delayed SSC and breastfeeding and routine newborn care Receives: Other: Delayed SSC and breastfeeding after CS; Other: Routine newborn care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of neonatal hypoglycemia
Neonatal blood glucose levels were assessed using the Stat Strip Xpress glucose meter at 1, 3, and 6 hours after birth. Hypoglycemia was categorized as follows: mild hypoglycemia (overall) at <45 mg/dL, moderate-to-severe at <36 mg/dL, and severe at <18 mg/dL. Treatment was initiated if levels dropped below 25 mg/dL or if symptoms like shakiness, tachycardia, pallor, hypothermia, hunger, sweating, or weakness appeared. In such cases, 10 ml/kg of formula was administered, followed by a recheck after 0.5 hour. If levels rise above 40 mg/dL, subsequent checks occurred every 3 hours. Persistent levels below 50 mg/dL necessitated continued formula feeding and monitoring, or transferred to neonatal care if needed.
Measured: 1, 3, and 6 hours after birth
Secondary outcomes (4)
Breastfeeding initiation time
Characterized by newborns correctly latching onto the nipple and areola, and establishing regular, effective sucking and swallowing.
Measured: Assessment occurs immediately post-operation, with timing recorded to the minute.
Duration of first breastfeeding
Start Timing at Latch-On: Begin timing when the infant first latches onto the breast.
End Timing at Detachment: Stop timing when the infant detaches from the breast, either naturally or with assistance from the mother or healthcare provider.
Measured: Assessment occurs immediately post-operation, with timing recorded to the minute.
Onset of lactogenesis II
Marked by significant milk secretion perceived by the mother as breast fullness, confirmed by observing and squeezing the areola to assess milk spillage.
Measured: The assessment occurs from surgery to pre-discharge, with timing recorded to the hour postpartum, an average of 72 hours.
Exclusive breastfeeding rate during hospitalization
This rate was calculated for mothers who underwent cesarean delivery in both study groups.
Measured: The assessment occurs from delivery to pre-discharge, an average of 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Jul 2023
- Primary completion15 May 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neonatal HypoglycemiaStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qingdao Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Qiao, Qingdao Municipal Hospital
- Investigators
- Jia Qiao, Principal investigator, Qingdao Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543160
- Sponsor's protocol ID
- Grant No.(2023LinShenZi No.123
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The paper needs to be submitted and published on a subscription basis, which has a longer cycle. Additionally, the data needs to be used for another paper, making it inconvenient to share.
Publications
Cuschieri S. The CONSORT statement. Saudi J Anaesth. 2019 Apr;13(Suppl 1):S27-S30. doi: 10.4103/sja.SJA_559_18.
PubMed 30930716Wang X, Zhang X, Sobel HL, Li Z, Juan J, Yang H. Early essential newborn care for cesarean section newborns in China: study protocol for a multi-centered randomized controlled trial. Trials. 2022 Aug 19;23(1):696. doi: 10.1186/s13063-022-06615-z.
PubMed 35986372Roeper M, Hoermann H, Kummer S, Meissner T. Neonatal hypoglycemia: lack of evidence for a safe management. Front Endocrinol (Lausanne). 2023 Jun 8;14:1179102. doi: 10.3389/fendo.2023.1179102. eCollection 2023.
PubMed 37361517
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Skin-to-Skin Contact and Breastfeeding During Caesarean Section: A Randomized Controlled Trial on Early Neonatal Hypoglycemia in Late Preterm and Term Infants
- ClinicalTrials.gov ID
- NCT06543160
- Acronym / sponsor ID
- Grant No.(2023LinShenZi No.123
- Conditions
- Neonatal Hypoglycemia
- Keywords
- neonatal hypoglycemia, skin-to-skin contact, breastfeeding, cesarean section, lactogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Qingdao Municipal HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 7 Aug 2024 (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.
Background: Neonatal hypoglycemia is a prevalent and serious condition among late preterm and term infants, which can lead to severe neurodevelopmental consequences if not managed properly. Immediate skin-to-skin contact (SSC) and early initiation of breastfeeding are recognized as effective interventions to stabilize glucose levels and support neonatal adaptation to extrauterine life. However, implementing these practices during cesarean sections (CS) presents challenges due to the need to maintain a sterile surgical environment and logistical complexities.
Objective: This study aims to evaluate the effects of immediate SSC and early breastfeeding initiation during CS on neonatal hypoglycemia and breastfeeding outcomes.
Methods: A randomized controlled trial was conducted with 336 mother-neonate pairs undergoing elective CS. Participants were randomly assigned to either the experimental group, which received immediate SSC and early breastfeeding during CS, or the control group, which received standard care. Blood glucose levels of neonates were monitored at 1, 3, and 6 hours post-birth. Additional outcomes included the time to breastfeeding initiation, duration of the first breastfeeding session, onset of lactogenesis II, and the rate of exclusive breastfeeding during hospitalization.
Detailed description
Neonatal hypoglycemia is a common condition among late preterm and term infants. It can lead to severe neurodevelopmental consequences if not managed properly. Immediate skin-to-skin contact (SSC) and early initiation of breastfeeding are effective interventions for stabilizing glucose levels and supporting neonatal adaptation to extrauterine life. While these practices are well-documented for their benefits in vaginal births, their implementation during cesarean sections (CS) presents challenges due to the need for maintaining a sterile surgical environment and the logistical complexities involved. The primary objective of this study was to evaluate the effects of immediate SSC and early breastfeeding initiation during CS on neonatal hypoglycemia and breastfeeding outcomes in late preterm and term infants.
This study was designed as a pragmatic, parallel-design, two-arm randomized controlled trial. It was conducted at Qingdao Municipal Hospital in China from July 2023 to July 2024. A total of 336 eligible mother-neonate pairs undergoing elective CS were included in the study.
Participants included mothers aged 18 years or older with a singleton pregnancy and gestational age between 34+1 and 41+6 weeks, undergoing elective CS with epidural or spinal anesthesia, willing to engage in SSC and breastfeeding during and after surgery, and newborns with Apgar scores above 8 at 1 and 5 minutes, a strong sucking reflex, and no critical conditions requiring transfer. Exclusion criteria involved serious pregnancy complications (e.g., placenta previa, eclampsia), conditions hindering SSC initiation (e.g., neonatal asphyxia, maternal excessive bleeding), and previous breast surgeries or medications affecting breastfeeding.
Participants were randomly assigned to either the experimental group (immediate SSC and early breastfeeding during CS) or the control group (standard care) using a block randomization sequence generated by Microsoft Excel 2010. The randomization process was centrally managed, with blinding maintained for staff performing SSC and data collectors, though patient blinding was not feasible.
Interventions:
Experimental Group:
- SSC and Breastfeeding During CS: Immediately after delivery, the surgical drape was lowered for parents to witness the birth. The neonate was placed prone on the mother's chest and dried within 20-30 seconds. Breastfeeding was initiated as soon as possible, and SSC continued throughout the surgery and for at least 90 minutes post-transfer to the ward.
- Routine Newborn Care: Included standard newborn care such as eye care, vitamin K1 administration, immunizations, and weighing, conducted before transferring the neonate to the ward.
Control Group:
- Delayed SSC and Breastfeeding: SSC was initiated within one hour after birth and maintained for at least 90 minutes post-surgery. The neonate was dried within 20-30 seconds after birth and sent to the ward while the mother completed the surgery.
- Routine Newborn Care: Similar to the experimental group.
Outcome Measures:
Primary Outcome: Incidence of neonatal hypoglycemia, with blood glucose levels monitored at 1, 3, and 6 hours post-birth using the Stat Strip Xpress glucose meter. Hypoglycemia was categorized as mild (<45 mg/dL), moderate-to-severe (<36 mg/dL), and severe (<18 mg/dL).
Secondary Outcomes: Included time to breastfeeding initiation, duration of the first breastfeeding session, onset of lactogenesis II (significant milk secretion perceived by the mother), and rate of exclusive breastfeeding during hospitalization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate SSC and early breastfeeding during CS group | Experimental | Other: Immediate SSC and early breastfeeding during CS, Other: Routine newborn careReceiving immediate SSC and early breastfeeding during CS and routine newborn care |
| control group | Other | Other: Delayed SSC and breastfeeding after CS, Other: Routine newborn careReceiving delayed SSC and breastfeeding and routine newborn care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- mothers aged 18 years or older with a singleton pregnancy, gestational age between 34+1 and 41+6 weeks.
- undergoing elective cesarean section with epidural, subarachnoid block, or combined spinal-epidural anesthesia, willing to engage in mother-infant SSC during and after the surgery, without experiencing severe reactions to anesthesia like vomiting or shivering that could affect SSC.
- having intention to breastfeed with no major contraindications (e.g., hepatitis B, syphilis, HIV, or other infectious diseases).
- newborns with Apgar scores above 8 at 1 and 5 minutes, a strong sucking reflex, and no critical neonatal conditions requiring transfer.
Key exclusion criteria (3 listed)
- serious pregnancy complications such as placenta previa, placenta accreta spectrum, eclampsia, and grade 3 or higher cardiac issues per NYHA standards.
- challenges in initiating mother-infant SSC include emergencies such as neonatal asphyxia or respiratory distress, maternal excessive bleeding during surgery, and maternal infectious dermatoses.
- previous breast surgeries such as biopsies or augmentations, nipple inversions complicating breastfeeding, or taking medications affecting lactation.
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 |
|---|---|---|
| Immediate SSC and early breastfeeding during CSUpon birth, the neonate is promptly placed prone on the mother's chest, with their head turned to one side for optimal skin contact. The drying process begins within 5 seconds and is completed within 20 to 30 seconds while the neonate remains on the mother's chest. Delayed cord clamping is practiced, with the cord clamped approximately 1-3 minutes after birth. Breastfeeding cues such as tongue movements or head turning are monitored, and the obstetric nurse assists the mother in initiating breastfeeding as soon as possible. SSC continues throughout the cesarean procedure, and upon completion, the newborn is temporarily separated from the mother for safety during transfer to the surgical cart. SSC is resumed immediately post-transfer and continues for a cumulative duration of at least 90 minutes. The neonate's skin color, breathing, and feeding responses are continuously observed. | Other | Immediate SSC and early breastfeeding during CS group |
| Delayed SSC and breastfeeding after CSThe neonate is dried within 20-30 seconds after birth, the cord is clamped after 1-3 minutes, and then the neonate is sent to the ward to wait for the mother to complete the surgery. Immediate SSC is initiated within one hour after birth and maintained with the mother for at least 90 minutes post-surgery, during which the neonate's skin color and breathing are continuously monitored. The obstetric nurse supports the mother in initiating breastfeeding at the earliest opportunity. | Other | control group |
| Routine newborn careNewborn eye care, vitamin K1 administration, immunizations, weighing, and standard examinations are conducted before the neonate is transferred to the ward. | Other | Immediate SSC and early breastfeeding during CS group, control group |
Primary outcome
Incidence of neonatal hypoglycemia
Time frame: 1, 3, and 6 hours after birth
Neonatal blood glucose levels were assessed using the Stat Strip Xpress glucose meter at 1, 3, and 6 hours after birth. Hypoglycemia was categorized as follows: mild hypoglycemia (overall) at <45 mg/dL, moderate-to-severe at <36 mg/dL, and severe at <18 mg/dL. Treatment was initiated if levels dropped below 25 mg/dL or if symptoms like shakiness, tachycardia, pallor, hypothermia, hunger, sweating, or weakness appeared. In such cases, 10 ml/kg of formula was administered, followed by a recheck after 0.5 hour. If levels rise above 40 mg/dL, subsequent checks occurred every 3 hours. Persistent levels below 50 mg/dL necessitated continued formula feeding and monitoring, or transferred to neonatal care if needed.
4 secondary outcomes
Breastfeeding initiation time
Time frame: Assessment occurs immediately post-operation, with timing recorded to the minute.
Duration of first breastfeeding
Time frame: Assessment occurs immediately post-operation, with timing recorded to the minute.
Onset of lactogenesis II
Time frame: The assessment occurs from surgery to pre-discharge, with timing recorded to the hour postpartum, an average of 72 hours.
Exclusive breastfeeding rate during hospitalization
Time frame: The assessment occurs from delivery to pre-discharge, an average of 5 days.
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 7 Aug 2024.
- Background: PubMed 30930716Cuschieri S. The CONSORT statement. Saudi J Anaesth. 2019 Apr;13(Suppl 1):S27-S30. doi: 10.4103/sja.SJA_559_18.
- Background: PubMed 35986372Wang X, Zhang X, Sobel HL, Li Z, Juan J, Yang H. Early essential newborn care for cesarean section newborns in China: study protocol for a multi-centered randomized controlled trial. Trials. 2022 Aug 19;23(1):696. doi: 10.1186/s13063-022-06615-z.
- Background: PubMed 37361517Roeper M, Hoermann H, Kummer S, Meissner T. Neonatal hypoglycemia: lack of evidence for a safe management. Front Endocrinol (Lausanne). 2023 Jun 8;14:1179102. doi: 10.3389/fendo.2023.1179102. eCollection 2023.
- Individual participant dataSharing planned: No. The paper needs to be submitted and published on a subscription basis, which has a longer cycle. Additionally, the data needs to be used for another paper, making it inconvenient to share.
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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.
Jia Qiao principal investigator
Qingdao Municipal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate SSC and early breastfeeding during CS, Delayed SSC and breastfeeding after CS and Routine newborn care in people with Neonatal Hypoglycemia, run by Qingdao Municipal Hospital at 1 site in China.
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 4 inclusion and 3 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 7 Aug 2024. 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 China. 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?
Incidence of neonatal hypoglycemia (time frame: 1, 3, and 6 hours after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06543160, which also lists 3 linked publications.
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 7 Aug 2024.