Iron DeficiencyNCT02728141
Healthy Infant Development Project - Sucrose Component
A study testing Water and Sucrose in people with Iron Deficiency, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in China.
Trial summary
Iron deficiency affects the opioid and dopamine systems in rodent models, with a higher pain threshold. The opioid system is involved in sucrose's ability to reduce pain and distress during neonatal procedures. Thus, prenatal iron deficiency might affect response to pain and sucrose analgesia. Read more about this study
- Who is it for?
- Ages 1 day to 5 days
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Water and Sucrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 424 participants
- Where
- 1 siteChina
- Study dates
- Nov 2009to Jun 2014
- 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 1 day to 5 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Full term healthy neonates participating in the Healthy Infant Development RCT (NCT00613717) in the folic acid/early postnatal placebo group and pre- and early postnatal iron-supplemented infants.
Who cannot join
- birth weight < 2500 g gestational age ≤ 37 wk major perinatal complications major congenital anomaly multiple birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts - Sucrose Component
Iron deficiency affects the opioid and dopamine systems in rodent models, with a higher pain threshold. The opioid system is involved in sucrose's ability to reduce pain and distress during neonatal procedures. Thus, prenatal iron deficiency might affect response to pain and sucrose analgesia. In order to compare response to pain and sucrose during heel stick in neonates with and without iron deficiency, healthy full-term Chinese infants were randomized to receive sucrose or water by syringe beforehand, in conjunction with heel stick for metabolic screening.
- Conditions
- Iron Deficiency
- Being tested
- Water, Sucrose
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterOther
2 ml distilled water by syringe one time in the newborn's mouth 2 minutes before heel stick
SucroseOther
2 ml 25% sucrose in distilled water by syringe one time in the newborn's mouth 2 minutes before heel stick
| Study group | Role | What they receive |
|---|---|---|
| Water | Placebo comparator | Newborn infants with ID numbers ending in odd numbers offered 2ml distilled water by syringe once in the side of the infant's mouth 2 minutes before heel stick. Receives: Other: Water |
| Sucrose | Active comparator | Newborn infants with ID numbers ending in even numbers offered 2 ml 25% sucrose in distilled water by syringe once in the side of the infant's mouth 2 minutes before heel stick. Receives: Other: Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant behavior (emotion regulation)
Infant behavior observed included activity level, negative emotionality, alertness and soothability.
Measured: up to 5 days old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startNov 2009
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Betsy Lozoff, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728141
- Sponsor's protocol ID
- 1R01HD052069
- Status last verified
- Mar 2016
- First submitted
- 30 Mar 2016
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: On request after main findings are published.
Publications
Lumeng JC, Li X, He Y, Gearhardt A, Sturza J, Kaciroti NA, Li M, Asta K, Lozoff B. Greater analgesic effects of sucrose in the neonate predict greater weight gain to age 18 months. Appetite. 2020 Mar 1;146:104508. doi: 10.1016/j.appet.2019.104508. Epub 2019 Nov 4.
PubMed 31698014
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts - Sucrose Component
- ClinicalTrials.gov ID
- NCT02728141
- Acronym / sponsor ID
- 1R01HD052069
- Conditions
- Iron Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Nov 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Apr 2016 (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.
Iron deficiency affects the opioid and dopamine systems in rodent models, with a higher pain threshold. The opioid system is involved in sucrose's ability to reduce pain and distress during neonatal procedures. Thus, prenatal iron deficiency might affect response to pain and sucrose analgesia. In order to compare response to pain and sucrose during heel stick in neonates with and without iron deficiency, healthy full-term Chinese infants were randomized to receive sucrose or water by syringe beforehand, in conjunction with heel stick for metabolic screening.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water | Placebo comparator | Other: WaterNewborn infants with ID numbers ending in odd numbers offered 2ml distilled water by syringe once in the side of the infant's mouth 2 minutes before heel stick. |
| Sucrose | Active comparator | Other: SucroseNewborn infants with ID numbers ending in even numbers offered 2 ml 25% sucrose in distilled water by syringe once in the side of the infant's mouth 2 minutes before heel stick. |
Who may qualify
- Ages
- 1 day to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Full term healthy neonates participating in the Healthy Infant Development RCT (NCT00613717) in the folic acid/early postnatal placebo group and pre- and early postnatal iron-supplemented infants.
Key exclusion criteria (1 listed)
- birth weight < 2500 g gestational age ≤ 37 wk major perinatal complications major congenital anomaly multiple birth
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 |
|---|---|---|
| Water2 ml distilled water by syringe one time in the newborn's mouth 2 minutes before heel stick | Other | Water |
| Sucrose2 ml 25% sucrose in distilled water by syringe one time in the newborn's mouth 2 minutes before heel stick | Other | Sucrose |
Primary outcome
Infant behavior (emotion regulation)
Time frame: up to 5 days old
Infant behavior observed included activity level, negative emotionality, alertness and soothability.
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 5 Apr 2016.
- Derived from this study: PubMed 31698014Lumeng JC, Li X, He Y, Gearhardt A, Sturza J, Kaciroti NA, Li M, Asta K, Lozoff B. Greater analgesic effects of sucrose in the neonate predict greater weight gain to age 18 months. Appetite. 2020 Mar 1;146:104508. doi: 10.1016/j.appet.2019.104508. Epub 2019 Nov 4.
- Individual participant dataSharing planned: Yes. On request after main findings are published.
Related trials for Iron Deficiency
Active, not recruitingObservational study
Ethnic Differences in Iron Absorption (FeGenes)
Anemia, Iron Deficiency, Iron Overload
Active, not recruiting
A Study to Evaluate the Effects of a Beef Liver Supplement on Energy, Mood, and Mental Clarity
Fatigue, Low Mood
Active, not recruitingObservational study
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
Anemia, Iron Deficiency, Iron Overload
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Recruiting
Safety and Efficacy of Iron Prophylaxis With on Iron Homeostasis in Healthy Pregnant Women
Iron Deficiency Anemia in Pregnancy, Iron Deficiency in 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.
Betsy Lozoff, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water and Sucrose in people with Iron Deficiency, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 1 inclusion and 1 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 5 Apr 2016. 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. Some participants in this study may receive a placebo. 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?
Infant behavior (emotion regulation) (time frame: up to 5 days old). 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 NCT02728141, which also lists 1 linked publication.
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 5 Apr 2016.