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Small for Gestational Age (SGA) InfantsNCT02421445

An Observational Study to Characterize Human Milk From Mothers Delivering Term SGA and AGA Infants.

An observational study of Small for Gestational Age (SGA) Infants and Appropriate for Gestational Age (AGA) Infants, run by Société des Produits Nestlé (SPN) at 3 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an observational study to characterize human milk of mothers delivering term SGA and term AGA infants. This is an observational, exploratory, longitudinal (from birth to 6 months postpartum), 4 parallel groups, and multi-centric study. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
How many people
142 participants
Where
3 sitesIndia
Study dates
Apr 2015to 30 Dec 2018
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 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Healthy (normal BMI) and undernourished (low BMI) women volunteers

Who may be able to join

  • All mothers who delivered term infants, either SGA or AGA
  • Mothers between 18 and 40 years of age inclusive, at the time of enrolment
  • Having decided to predominantly breast-feed their new born baby at least until 6 months of age
  • Having permanent residence at a maximum distance of 50km from the hospital/center of investigation for the duration of this study and being able to follow all the steps of this study
  • Willing to provide informed consent according to the requirements of local regulations.

Who cannot join

  • Preterm delivery (≤ 36 weeks + 6 days completed) of gestational age)
  • Currently participating or having participated in an interventional clinical trial during the last 4 weeks prior to the beginning of this study
  • Having a BMI ≥ 25.0
  • Chewing tobacco, smoking or drinking alcohol (> 1 glass per day), consuming illicit drugs during pregnancy or/and duration of the study
  • Presenting any disease or medical condition which might prevent breast-feeding or collecting the human milk samples or for which breast-feeding is contraindicated
  • Having diabetes or gestational diabetes mellitus
  • Presenting dietary problems/illnesses such as anorexia, bulimia and celiac disease
  • Subject unable to comply with study procedures or unable to come to hospital for the study visits.

Trial locations and contacts

3 sites in 1 country.

India3 sites

  • Muzumdar Shaw Medical Centre

    Delhi, Bangalore, 560099

  • Aadithya Adhikari Hospital

    Mysore, Karnataka, 570002

  • Sir Ganga Ram Hospital

    New Delhi, 110060

Other trials in India

About this study

This is an observational study to characterize human milk of mothers delivering term SGA and term AGA infants. This is an observational, exploratory, longitudinal (from birth to 6 months postpartum), 4 parallel groups, and multi-centric study. Total 300 subjects will be randomised in the study assuming 20% dropout, 240 subjects will be enrolled. The recruitment period for the study in India is for 6 months.

Read the detailed description

This is an observational study to characterize human milk of mothers delivering term SGA and term AGA infants. This is an observational, exploratory, longitudinal (from birth to 6 months postpartum), 4 parallel groups, and multi-centric study. Total 300 subjects will be randomised in the study assuming 20% dropout, 240 subjects will be enrolled. The recruitment period for the study in India is for 6 months.

The Primary Objective of the study is to characterize and quantify maternal milk composition from mothers of adequately nourished and under nourished status delivering term Small for Gestational Age (SGA) infants, compared to adequately-nourished and undernourished mothers delivering term Appropriate for Gestational Age (AGA) infants as defined in Fenton growth chart 2013.

The secondary objective of the study is-

  1. Association of maternal milk components with dietary intake and nourishment status of the mother.
  2. Associations of maternal and infant clinical parameters to maternal milk nutrients.
  3. To explore and analyze additional functional milk components, such as triacylglycerol, cholesterols, carotenoids, vitamins, microbiota, peptide profile, microRNA, cytokines, growth factors and hormones.

The subject will enroll in the study after signing the Informed Consent Form after delivery the infants (i.e. term AGA \& term SGA) within 72 hours. Total Duration of the study for subject is 24 weeks. Sponsor will notify the end of study after 90 days of last subject last visit. Principal Investigator responsibility is to detect and document AE and SAE

Medical subject headings
Alopecia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal Milk Composition Characterization and Quantification

    Milk samples collected for analyses of functional milk components, such as macronutrients (total fat, total protein, total lactose, total energy, crude proteins and total solids) and total protein analysis by BCA kit.

    Measured: Visit 1 (Delivery - up to 72 hr post partum)

  2. Maternal Milk Composition Characterization and Quantification

    Milk samples collected for analyses of functional milk components, such as macronutrients (total fat, total protein, total lactose, total energy, crude proteins and total solids) and total protein analysis by BCA kit.

    Measured: Visit 2 ( 6 week )

  3. Maternal Milk Composition Characterization and Quantification

    Milk samples collected for analyses of functional milk components, such as macronutrients (total fat, total protein, total lactose, total energy, crude proteins and total solids) and total protein analysis by BCA kit.

    Measured: Visit 3 (10 Week)

  4. Maternal Milk Composition Characterization and Quantification

    Milk samples collected for analyses of functional milk components, such as macronutrients (total fat, total protein, total lactose, total energy, crude proteins and total solids) and total protein analysis by BCA kit.

    Measured: Visit 4 (14 week)

  5. Maternal Milk Composition Characterization and Quantification

    Milk samples collected for analyses of functional milk components, such as macronutrients (total fat, total protein, total lactose, total energy, crude proteins and total solids) and total protein analysis by BCA kit.

    Measured: Visit 5 (24 week)

Secondary outcomes (6)

  1. Dietary intake

    Assessed by a dietary questionnaire and correlated to infants and mothers'characteristics.

    Measured: 3 consecutive days the week prior visit 2 (6 Week)

  2. Dietary intake

    Assessed by a dietary questionnaire and correlated to infants and mothers'characteristics.

    Measured: 3 consecutive days prior to visit 3 (10 Week)

  3. Dietary intake

    Assessed by a dietary questionnaire and correlated to infants and mothers'characteristics.

    Measured: 3 consecutive days prior to visit 4 (14 week)

  4. Dietary intake

    Assessed by a dietary questionnaire and correlated to infants and mothers'characteristics.

    Measured: 3 consecutive days prior to visit 5 (24 week)

  5. Maternal milk composition analysis

    Other exploratory analyses such as fatty acids, cholesterol, phospholipids, gangliosides, oligosaccharides, peptides, amino acids, minerals, triacylglycerol, carotenoids, vitamins, microbiota, peptide profile, microRNA, cytokines, growth factors and hormones.

    Measured: 5 visits from post delivery to 24 weeks.

  6. Associations of maternal and infant clinical parameters to maternal milk nutrients

    Correlation of maternal milk composition to mother's diet, stage of lactation, type of delivery, sex of the infant, single/multiple birth, infant anthropometric measures (weight, length and head circumference), gestational age at birth and birth anthropometrics.

    Measured: 5 visits from post delivery to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completion30 Jun 2018
  4. Study completion30 Dec 2018

Resources

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
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02421445
Sponsor's protocol ID
12.23 NRC
Status last verified
Apr 2019
First submitted
1 Apr 2015
Last updated
24 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Small for Gestational Age (SGA) Infants and Appropriate for Gestational Age (AGA) Infants, run by Société des Produits Nestlé (SPN) at 3 sites in India.

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 5 inclusion and 8 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 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in India. 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?

Maternal Milk Composition Characterization and Quantification (time frame: Visit 1 (Delivery - up to 72 hr post partum)). The study lists 5 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 NCT02421445.

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 24 Apr 2019.

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