Pregnancy PretermMELIPNCT01340417
Melatonin Levels in Preterm and Term Newborn Infants
A study testing Measurements of melatonin levels in urine, blood, milk. in people with Pregnancy Preterm, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The general goal of the present study is to examine the developmental changes caused by melatonin in preterm and term newborns. The major brain lesions associated with cerebral palsy and cognitive impairment in preterm infants are periventricular white matter damage (WMD). Read more about this study
- Who is it for?
- Ages 24 to 41 weeks
- Conditions the study is for
- Pregnancy Preterm
- What is being tested?
- Measurements of melatonin levels in urine, blood, milk.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to Jun 2013
- 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 24 to 41 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Mother:
- Consent forms from mother or guardian
- Age ≥ 18 years
- Mother Heath insurance
- Newborn:
- Infants born between 24+0 et 41+6 weeks of gestation
- Infants with informed consent from mother or guardian and mother's social insurance
Who cannot join
- Mother:
- Chronic pathology
- Treatment: Carbamazepine, betablockers, rifampicin, quinolones, cimetidine, 5-Methoxypsoralen or bergapten, 8- methoxypsoralen (or Methoxsalen), CIRCADIN®
- Newborn :
- Congenital malformations
- Dermatosis
- Treatment: cimetidine
Trial locations and contacts
1 site in 1 country.
About this study
The general goal of the present study is to examine the developmental changes caused by melatonin in preterm and term newborns.
The major brain lesions associated with cerebral palsy and cognitive impairment in preterm infants are periventricular white matter damage (WMD). At the present time, despite major improvements in neonatal care, there are no established therapeutic regimens for the treatment of brain lesions in preterms. Melatonin is secreted by the pineal gland; melatonin's neuroprotective action has been well documented in animal experimental models. Neuroprotection is believed to stem from its direct free radical scavenging, indirect antioxidant activities.
Read more
Originality Several reports have described melatonin secretion in older children, but only a few have observed melatonin concentrations during the first year of life. Very little is known about the fetal pineal melatonin synthesis and nothing at what prenatal age melatonin synthesis starts. Premature infants have a 3 months delay in the development of melatonin rhythmicity compared to full-term infants. One study found discordant data with decreasing melatonin value around term. The absence of longitudinal study and the low number of children included make the interpretation difficult of the secretion of melatonin at the newborn.
Hypothesis: Infants born before 28 weeks gestation have melatonin deficiency (50pg/ml), compared to newborns at term (100pg/ml).
Study design: prospective, longitudinal, multicenter trial in 3 Neonatal Intensive Care Units in Ile de France. Specific aim is to compare the developmental changes of melatonin in preterm and term newborns (200 infants and their mothers: 4 groups of 50 infants: 24-27GA +6d ; 28-32 GA +6d ; 33-36 GA +6d ; 37-41 GA +6d). Secondary aims are the following:
- determine Melatonin creatinin excretion in preterm infants
- correlate between serum melatonin secretion and urinary melatonin and 6-sulfatoxymelatonin excretion
- determine endogenous melatonin production in the human pineal
- correlate genetic variations between different levels of melatonin in premature infants
- assess clinical and neurological outcomes at term Clinical impact The present clinical project is part of a translational approach, expected data for infants born before 28 weeks gestation is melatonin deficiency which should participate in determining the potential use of melatonin as a neuroprotectant in human preterm neonates.
Read the detailed description
The general goal of the present study is to examine the developmental changes caused by melatonin in preterm compared to term newborns. This secretion is studied in child and mother's blood, child's urine, the mother's milk for the women who breastfeed (200 infants and their mothers: 4 groups of 50 infants: 24-27 gestational age (GA) +6d ; 28-32 GA +6d ; 33-36 GA +6d ; 37-41 GA +6d). Secondary aims are the following: determine Melatonin creatinin excretion in preterm infants, correlate between serum melatonin secretion and urinary melatonin and 6-sulfatoxymelatonin excretion, determine endogenous melatonin production in the human pineal, correlate genetic variations between different levels of melatonin in premature infants, assess clinical and neurological outcomes at term.
Study duration for each patient Study duration is one year (inclusion time: 9 months) Duration of mother's inclusion:3 days if delivery between 34 and 41+6d weeks of gestation (two blood samples in maternal vein and umbilical vein after delivery and one mother's milk sample on the third day after delivery, D3) 15 days to 3 months if delivery between 24 and 33+6d weeks of gestation (two blood samples in maternal vein and umbilical vein after delivery and mother's milk sample on the third day after delivery,D10-D15, D30, D60 until term age
Duration of infant's inclusion:
- 3 days if delivery between 34 and 41+6d weeks of gestation (1 blood sample on the third day (D3) after delivery and 4 urinary samples at birth and on D3)
- 15 days to 3 months if delivery between 24 and 33+6d weeks of gestation (blood and urinary samples on the third day after delivery,D10-D15, D30, D60 until term (37-42 weeks gestational age)
Population study All the preterm and term newborns in 3 participating centers, will be evaluated in term of eligibility. Their clinical characteristics will be compared to the criteria of inclusion and exclusion before entering into the study. The inclusion of the preterm from 24 GA is justified by the assumption of responsibility of more in earlier of this population in 2009 (limit of viability from 24 GA and/or birth weight > 500g).
The group of the term infants (37-41 GA +6d) will correspond to the inclusion of new-born babies in good health in maternity.
Descriptive analysis The quantitative variables will be described in the form of average (standard deviation) or median (quartiles) according to their Gaussian nature or not. The qualitative variables will be described by their manpower and frequency.
Analyzes of criteria of judgment The principal analysis will compare the rate of children deprived of melatonin between the 4 groups. This comparison will be carried out by a test of the chi-2 or Fisher if suitable. Nevertheless this analysis will be refined by modeling the plasmatic secretion according to the gestational age and of the hour of melatonin measurement. This modeling will use either a mixed model, or a nonlinear model like the models used into pharmacokinetic. In the same way will be modeled the urinary levels of melatonin and in the mother's milk by taking of account the same parameters as previously and the repetition of the measurements. Some parameters will be used like variables of adjustment like the luminous environment, the preeclampsia, the sex, the intrauterine growth restricted infants, multiple pregnancies, the way of childbirth.
The plan of statistical analysis will be finalized at the end of the study and before data management and will be the subject of Master into biostatistics.
The measurement of cortisol, parameters of the ionogram, urea, creatinin, serotonin will be compared between the 4 groups by using parametric tests (ANOVA) or not parametric (KRUSKALL-Wallis) according to the Gaussian nature or not of the variables. The other measurements (blood, urines) will be described in the course of time according to gestational age.
The analyzes will be carried out with software SAS 9.02 .
Clinical impact:
The present clinical project is part of a translational approach, expected data for infants born before 28 weeks gestation is melatonin deficiency which should participate, in addition with existing data and other ongoing studies in an animal model, in determining the potential use of melatonin as a neuroprotectant in human preterm neonates.
It's important to underline that this study must be considered as an interventional study. Indeed, in this study patients have many takings modality while in common practice patients haven't those takings:
- measurements of melatonin levels in urine, blood, milk
- measurements of Serum Cortisol concentrations and urinary excretion
- measurements of Serum Serotonin level
- Conditions
- Pregnancy Preterm
- Being tested
- Measurements of melatonin levels in urine, blood, milk.
- Keywords
- melatonin, preterm, deficiency, neuroprotection
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurements of melatonin levels in urine, blood, milk.Other
Measurements of melatonin levels in urine, blood, milk.
| Study group | Role | What they receive |
|---|---|---|
| one label | Experimental | Measurements of melatonin levels in urine, blood, milk. Receives: Other: Measurements of melatonin levels in urine, blood, milk. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of melatonin levels by radioimmunology
Primary outcomes are measurements of melatonin levels in urine, blood, milk. These procedures will be made by radioimmunology, to limit data variability. The reasoning will be made in coefficient of variation intra-test for a patient.
Measured: 3 days if delivery between 34 and 41+6d weeks of gestation
Measurements of melatonin levels by radioimmunology
Primary outcomes are measurements of melatonin levels in urine, blood, milk. These procedures will be made by radioimmunology, to limit data variability. The reasoning will be made in coefficient of variation intra-test for a patient.
Measured: 15 days to 3 months if delivery between 24 and 33+6d weeks of gestation
Secondary outcomes (4)
Serum Cortisol concentrations and urinary excretion
Serum Cortisol concentrations and urinary excretion
- Assay will use a volume of 20µl
- Sensitivity is of 15nmol/l
Measured: 3 days if delivery between 34 and 41+6d weeks of gestation
Serum Cortisol concentrations and urinary excretion
Serum Cortisol concentrations and urinary excretion
- Assay will use a volume of 20µl
- Sensitivity is of 15nmol/l
Measured: 15 days to 3 months if delivery between 24 and 33+6d weeks of gestation
Serum Serotonin level
Serum Serotonin level:
Liquid chromatography methods will be used to measure the serotonin rates (5-hydroxytryptamine, 5 HT) blood. The radioenzymatic techniques of reference will be implemented for the measurement of the enzymatic activities of the way of the melatonin (N-acetyl transferase [NAT or AANAT, EC. 2.3.1.5] and hydroxyindole O-methyltransferase [HIOMT or ASMT, EC. 2.1.1.4]) to the level of the blood plates.
Measured: 3 days if delivery between 34 and 41+6d weeks of gestation
Serum Serotonin level
Serum Serotonin level:
Liquid chromatography methods will be used to measure the serotonin rates (5-hydroxytryptamine, 5 HT) blood. The radioenzymatic techniques of reference will be implemented for the measurement of the enzymatic activities of the way of the melatonin (N-acetyl transferase [NAT or AANAT, EC. 2.3.1.5] and hydroxyindole O-methyltransferase [HIOMT or ASMT, EC. 2.1.1.4]) to the level of the blood plates.
Measured: 15 days to 3 months if delivery between 24 and 33+6d weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2013
- Study completionJun 2013
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 Pregnancy PretermStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie BIRAN, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340417
- Sponsor's protocol ID
- P091108
- Other IDs
- 2010-A01024-35
- Acronym
- MELIP
- Status last verified
- Sep 2013
- First submitted
- 30 Mar 2011
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Biran V, Decobert F, Bednarek N, Boizeau P, Benoist JF, Claustrat B, Barre J, Colella M, Frerot A, Garnotel R, Graesslin O, Haddad B, Launay JM, Schmitz T, Schroedt J, Virlouvet AL, Guilmin-Crepon S, Yacoubi A, Jacqz-Aigrain E, Gressens P, Alberti C, Baud O. Melatonin Levels in Preterm and Term Infants and Their Mothers. Int J Mol Sci. 2019 Apr 27;20(9):2077. doi: 10.3390/ijms20092077.
PubMed 31035572
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Levels in Preterm and Term Newborn Infants
- ClinicalTrials.gov ID
- NCT01340417
- Acronym / sponsor ID
- MELIP / P091108
- Conditions
- Pregnancy Preterm
- Keywords
- melatonin, preterm, deficiency, neuroprotection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Apr 2011 (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.
The general goal of the present study is to examine the developmental changes caused by melatonin in preterm and term newborns.
The major brain lesions associated with cerebral palsy and cognitive impairment in preterm infants are periventricular white matter damage (WMD). At the present time, despite major improvements in neonatal care, there are no established therapeutic regimens for the treatment of brain lesions in preterms. Melatonin is secreted by the pineal gland; melatonin's neuroprotective action has been well documented in animal experimental models. Neuroprotection is believed to stem from its direct free radical scavenging, indirect antioxidant activities.
Originality Several reports have described melatonin secretion in older children, but only a few have observed melatonin concentrations during the first year of life. Very little is known about the fetal pineal melatonin synthesis and nothing at what prenatal age melatonin synthesis starts. Premature infants have a 3 months delay in the development of melatonin rhythmicity compared to full-term infants. One study found discordant data with decreasing melatonin value around term. The absence of longitudinal study and the low number of children included make the interpretation difficult of the secretion of melatonin at the newborn.
Hypothesis: Infants born before 28 weeks gestation have melatonin deficiency (50pg/ml), compared to newborns at term (100pg/ml).
Study design: prospective, longitudinal, multicenter trial in 3 Neonatal Intensive Care Units in Ile de France. Specific aim is to compare the developmental changes of melatonin in preterm and term newborns (200 infants and their mothers: 4 groups of 50 infants: 24-27GA +6d ; 28-32 GA +6d ; 33-36 GA +6d ; 37-41 GA +6d). Secondary aims are the following:
- determine Melatonin creatinin excretion in preterm infants
- correlate between serum melatonin secretion and urinary melatonin and 6-sulfatoxymelatonin excretion
- determine endogenous melatonin production in the human pineal
- correlate genetic variations between different levels of melatonin in premature infants
- assess clinical and neurological outcomes at term Clinical impact The present clinical project is part of a translational approach, expected data for infants born before 28 weeks gestation is melatonin deficiency which should participate in determining the potential use of melatonin as a neuroprotectant in human preterm neonates.
Detailed description
The general goal of the present study is to examine the developmental changes caused by melatonin in preterm compared to term newborns. This secretion is studied in child and mother's blood, child's urine, the mother's milk for the women who breastfeed (200 infants and their mothers: 4 groups of 50 infants: 24-27 gestational age (GA) +6d ; 28-32 GA +6d ; 33-36 GA +6d ; 37-41 GA +6d). Secondary aims are the following: determine Melatonin creatinin excretion in preterm infants, correlate between serum melatonin secretion and urinary melatonin and 6-sulfatoxymelatonin excretion, determine endogenous melatonin production in the human pineal, correlate genetic variations between different levels of melatonin in premature infants, assess clinical and neurological outcomes at term.
Study duration for each patient Study duration is one year (inclusion time: 9 months) Duration of mother's inclusion:3 days if delivery between 34 and 41+6d weeks of gestation (two blood samples in maternal vein and umbilical vein after delivery and one mother's milk sample on the third day after delivery, D3) 15 days to 3 months if delivery between 24 and 33+6d weeks of gestation (two blood samples in maternal vein and umbilical vein after delivery and mother's milk sample on the third day after delivery,D10-D15, D30, D60 until term age
Duration of infant's inclusion:
- 3 days if delivery between 34 and 41+6d weeks of gestation (1 blood sample on the third day (D3) after delivery and 4 urinary samples at birth and on D3)
- 15 days to 3 months if delivery between 24 and 33+6d weeks of gestation (blood and urinary samples on the third day after delivery,D10-D15, D30, D60 until term (37-42 weeks gestational age)
Population study All the preterm and term newborns in 3 participating centers, will be evaluated in term of eligibility. Their clinical characteristics will be compared to the criteria of inclusion and exclusion before entering into the study. The inclusion of the preterm from 24 GA is justified by the assumption of responsibility of more in earlier of this population in 2009 (limit of viability from 24 GA and/or birth weight > 500g).
The group of the term infants (37-41 GA +6d) will correspond to the inclusion of new-born babies in good health in maternity.
Descriptive analysis The quantitative variables will be described in the form of average (standard deviation) or median (quartiles) according to their Gaussian nature or not. The qualitative variables will be described by their manpower and frequency.
Analyzes of criteria of judgment The principal analysis will compare the rate of children deprived of melatonin between the 4 groups. This comparison will be carried out by a test of the chi-2 or Fisher if suitable. Nevertheless this analysis will be refined by modeling the plasmatic secretion according to the gestational age and of the hour of melatonin measurement. This modeling will use either a mixed model, or a nonlinear model like the models used into pharmacokinetic. In the same way will be modeled the urinary levels of melatonin and in the mother's milk by taking of account the same parameters as previously and the repetition of the measurements. Some parameters will be used like variables of adjustment like the luminous environment, the preeclampsia, the sex, the intrauterine growth restricted infants, multiple pregnancies, the way of childbirth.
The plan of statistical analysis will be finalized at the end of the study and before data management and will be the subject of Master into biostatistics.
The measurement of cortisol, parameters of the ionogram, urea, creatinin, serotonin will be compared between the 4 groups by using parametric tests (ANOVA) or not parametric (KRUSKALL-Wallis) according to the Gaussian nature or not of the variables. The other measurements (blood, urines) will be described in the course of time according to gestational age.
The analyzes will be carried out with software SAS 9.02 .
Clinical impact:
The present clinical project is part of a translational approach, expected data for infants born before 28 weeks gestation is melatonin deficiency which should participate, in addition with existing data and other ongoing studies in an animal model, in determining the potential use of melatonin as a neuroprotectant in human preterm neonates.
It's important to underline that this study must be considered as an interventional study. Indeed, in this study patients have many takings modality while in common practice patients haven't those takings:
- measurements of melatonin levels in urine, blood, milk
- measurements of Serum Cortisol concentrations and urinary excretion
- measurements of Serum Serotonin level
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one label | Experimental | Other: Measurements of melatonin levels in urine, blood, milk.Measurements of melatonin levels in urine, blood, milk. |
Who may qualify
- Ages
- 24 to 41 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Mother:
- Newborn:
Key exclusion criteria (7 listed)
- Mother:
- Newborn :
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 |
|---|---|---|
| Measurements of melatonin levels in urine, blood, milk.Measurements of melatonin levels in urine, blood, milk. | Other | one label |
Primary outcome
Measurements of melatonin levels by radioimmunology
Time frame: 3 days if delivery between 34 and 41+6d weeks of gestation
Primary outcomes are measurements of melatonin levels in urine, blood, milk. These procedures will be made by radioimmunology, to limit data variability. The reasoning will be made in coefficient of variation intra-test for a patient.
Measurements of melatonin levels by radioimmunology
Time frame: 15 days to 3 months if delivery between 24 and 33+6d weeks of gestation
Primary outcomes are measurements of melatonin levels in urine, blood, milk. These procedures will be made by radioimmunology, to limit data variability. The reasoning will be made in coefficient of variation intra-test for a patient.
4 secondary outcomes
Serum Cortisol concentrations and urinary excretion
Time frame: 3 days if delivery between 34 and 41+6d weeks of gestation
Serum Cortisol concentrations and urinary excretion
Time frame: 15 days to 3 months if delivery between 24 and 33+6d weeks of gestation
Serum Serotonin level
Time frame: 3 days if delivery between 34 and 41+6d weeks of gestation
Serum Serotonin level
Time frame: 15 days to 3 months if delivery between 24 and 33+6d weeks of gestation
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 3 Feb 2023.
- Results publication: PubMed 31035572Biran V, Decobert F, Bednarek N, Boizeau P, Benoist JF, Claustrat B, Barre J, Colella M, Frerot A, Garnotel R, Graesslin O, Haddad B, Launay JM, Schmitz T, Schroedt J, Virlouvet AL, Guilmin-Crepon S, Yacoubi A, Jacqz-Aigrain E, Gressens P, Alberti C, Baud O. Melatonin Levels in Preterm and Term Infants and Their Mothers. Int J Mol Sci. 2019 Apr 27;20(9):2077. doi: 10.3390/ijms20092077.
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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.
Valérie BIRAN, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurements of melatonin levels in urine, blood, milk. in people with Pregnancy Preterm, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 7 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 3 Feb 2023. 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 France. 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?
Measurements of melatonin levels by radioimmunology (time frame: 3 days if delivery between 34 and 41+6d weeks of gestation). The study lists 2 primary outcomes in all. 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 NCT01340417, 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 3 Feb 2023.