Neonatal HypoglycemiaNCT00332449
Early Breast Feeding and Glucose Levels in High Risk Newborns
An observational study of Neonatal Hypoglycemia, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Early breast feeding has shown to be important to mother-infant bonding and is associated with longer duration of breast feeding. However, little data is available regarding its contribution to glucose levels in the newborn infants. Read more about this study
- Who is it for?
- Ages 1 to 1 day
- Conditions the study is for
- Neonatal Hypoglycemia
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2007to Dec 2008
- Phase
- Observational
- 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 1 to 1 day
- All sexes
- No healthy volunteers
- Child
Study population: primary clinic clinic
Who may be able to join
- Newborns to diabetic mothers
- Newborns to hypertensive mothers
- Newborns with birth weight greater than 4 Kg or less than 2.5 Kg
- Newborns with meconium stained amniotic fluid
Who cannot join
- Newborns with major congenital malformation
- Preterm babies
- Newborns with post-birth distress
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center - Neonatal Department
Ramat Gan, Tel-Hashomer, 52621
Ayala Maayan, MD, 972-3-530-2451, ayala.maayan@sheba.health.gov.il
About this study
Official title: Does Early Breast Feeding Prevents Neonatal Hypoglycemia in High Risk Newborns
Early breast feeding has shown to be important to mother-infant bonding and is associated with longer duration of breast feeding. However, little data is available regarding its contribution to glucose levels in the newborn infants. Newborns that are at risk to develop hypoglycemia may benefit from early breast feeding if this appears to prevent post-partum hypoglycemia.
Read the detailed description
Mothers will be encouraged to breast feed early after delivery (at the delivery room). Data of high risk babies for developing post partum hypoglycemia (Infants of diabetic mothers, infants of hypertensive mothers, infants with birth weight more than 4 Kg or less than 2.5 Kg and infants with meconium stained amniotic fluid)will be recorded including maternal breast feeding times and quality of feeding. Glucose levels shall be routinely monitored and recorded at the neonatal department. A comparison of all data will be made between those newborns that breast feed after labor and those who were not.
- Conditions
- Neonatal Hypoglycemia
- Keywords
- early breast feeding, hypoglycemia, newborn
- Medical subject headings
- Breast Feeding, Hypoglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
normal neonatal glucose levels
Measured: 2 days
Secondary outcomes (1)
Hypoglycemia prevention
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2006 (estimated)
- Study startJun 2007
- Primary completionJun 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Ayala Maayan-Metzger, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332449
- Sponsor's protocol ID
- SHEBA-06-4112-AM-CTIL
- Status last verified
- Apr 2008
- First submitted
- 31 May 2006
- Last updated
- 15 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Early Breast Feeding Prevents Neonatal Hypoglycemia in High Risk Newborns
- ClinicalTrials.gov ID
- NCT00332449
- Acronym / sponsor ID
- SHEBA-06-4112-AM-CTIL
- Conditions
- Neonatal Hypoglycemia
- Keywords
- early breast feeding, hypoglycemia, newborn
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jun 2007
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 1 Jun 2006 (estimated)
- 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.
Early breast feeding has shown to be important to mother-infant bonding and is associated with longer duration of breast feeding. However, little data is available regarding its contribution to glucose levels in the newborn infants. Newborns that are at risk to develop hypoglycemia may benefit from early breast feeding if this appears to prevent post-partum hypoglycemia.
Detailed description
Mothers will be encouraged to breast feed early after delivery (at the delivery room). Data of high risk babies for developing post partum hypoglycemia (Infants of diabetic mothers, infants of hypertensive mothers, infants with birth weight more than 4 Kg or less than 2.5 Kg and infants with meconium stained amniotic fluid)will be recorded including maternal breast feeding times and quality of feeding. Glucose levels shall be routinely monitored and recorded at the neonatal department. A comparison of all data will be made between those newborns that breast feed after labor and those who were not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- primary clinic clinic
Key inclusion criteria (4 listed)
- Newborns to diabetic mothers
- Newborns to hypertensive mothers
- Newborns with birth weight greater than 4 Kg or less than 2.5 Kg
- Newborns with meconium stained amniotic fluid
Key exclusion criteria (3 listed)
- Newborns with major congenital malformation
- Preterm babies
- Newborns with post-birth distress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
normal neonatal glucose levels
Time frame: 2 days
1 secondary outcome
Hypoglycemia prevention
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2008.
Related trials for Neonatal Hypoglycemia
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
RecruitingPhase 4
Pasteurised Donor Human Milk Supplementation for Term Babies
Neonatal Hypoglycemia, Metabolic Complication
Not yet recruiting
Umbilical Cord Glucose
Congenital Hyperinsulinism (CHI)
Active, not recruitingPhase 2
HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
Congenital Hyperinsulinism
Recruiting
Automated Insulin for Management of Intrapartum Glycemia
Type 1 Diabetes (T1D), Pregnancy
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.
Ayala Maayan-Metzger, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Hypoglycemia, run by Sheba Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 15 Apr 2008. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayala Maayan, MD (972-3-530-2043, ayala.maayan@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
normal neonatal glucose levels (time frame: 2 days). 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 15 Apr 2008.