DHANI-2 is an extension to DHANI (NCT01580345) which proposes to extend maternal supplementation (DHA or Placebo) from \<20 weeks of gestational age through 6 months postpartum and infant follow-up through 12 months. Leveraging the Randomized Controlled Trial (RCT) design, DHANI-2 aims to assess the role of maternal DHA supplementation on infant neurodevelopment and body growth. It also intends to enhance the mechanistic understanding by the addition of repeated biochemical measures from mother-child dyads.
A double-blinded, randomized, placebo controlled trial would be conducted among pregnant women in India to test the effectiveness of supplementing pregnant Indian women with 400 mg/d algal DHA compared to placebo from mid-pregnancy through delivery. Eligible participants would be randomized to receive either 400 mg of DHA or a placebo baseline measures would be taken before the enrollment of the participant in the study. The mother-child dyads would be followed through infant age 1 year and anthropometric measurements and biochemical investigations would be used to assess the effect of maternal DHA supplementation on infant neurodevelopment at ages 6- and 12-months using validated the Development Assessment Scale for Indian Infants (DASII).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
957
400 mg/day of Docosa-hexaenoic Acid (algal DHA) will given to the pregnant women (in the active group) from ≤20 weeks of gestation through 6 months postpartum.
400 mg/day of placebo (corn/soy oil) will be given to the pregnant women from ≤20 weeks of gestation through 6 months postpartum.
KLEUs Jawaharlal Nehru Medical College -- Prabhakar Kore Charitable Hospital
Belagavi, Karnataka, India
Infant neurodevelopment as measured by his/her Development quotient scores (DQS) at 12 months of age
The development quotient (DQ) among infants at 12 months of age assessed using the standardized Development Assessment Scale for Indian Infants (DASII). DASII is the Indian modification (done in 1970 and 1977) of the Bayley Scale of Infant Development (BSID) using Indian norms for 67 motor and 163 mental items of the BSID. DASII provides a measure of DQ among Indian infants below 30 months of age. DQ is defined as the ratio of functional to chronological age. Third, 50th and 97th percentile norms are given. A higher score indicates a better outcome. The maximum DQ score is 100; ≥85 is normal; 71-84 is mild to moderate delay and developmental delay is defined as DQ ≤70 (≤2SD). Median reliability index for motor and mental scales based on correlation between consecutive months is noted to be 0.88 for motor scales and 0.91 for mental scales.
Time frame: 12 months (± 4 weeks)
Mean difference in infant developmental quotient (DQ) at 6 month
Mean Difference in the infant developmental quotient (DQ) as measured by the Development Assessment Scale for Indian Infants (DASII) at 6 months. DASII is the Indian modification (done in 1970 and 1977) of the Bayley Scale of Infant Development (BSID) using Indian norms for 67 motor and 163 mental items of the BSID. DASII provides a measure of DQ among Indian infants below 30 months of age. DQ is defined as the ratio of functional to chronological age. Third, 50th and 97th percentile norms are given. A higher score indicates a better outcome. The maximum DQ score is 100; ≥85 is normal; 71-84 is mild to moderate delay and developmental delay is defined as DQ ≤70 (≤2SD).
Time frame: 6 months (± 4 weeks)
Mean difference in infant motor score at 6 month
Mean Difference in the motor score as measured by the Development Assessment Scale for Indian Infants (DASII) at 6 months. DASII is the Indian modification (done in 1970 and 1977) of the Bayley Scale of Infant Development (BSID) using Indian norms for 67 motor and 163 mental items of the BSID. A higher score indicates a better outcome. The motor development items cover the child's development from supine to erect posture, neck-control, locomotion etc. It also includes the record for manipulative behaviour such as reaching, picking-up, handling things etc.
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Time frame: 6 (± 4 weeks)
Mean difference in infant mental score at 6 month
Mean Difference in the mental score as measured by the Development Assessment Scale for Indian Infants (DASII) at 6 months. DASII is the Indian modification (done in 1970 and 1977) of the Bayley Scale of Infant Development (BSID) using Indian norms for 67 motor and 163 mental items of the BSID. A higher score indicates a better outcome. The mental development items record the child's cognizance of objects in the surroundings, perceptual pursuit of moving objects, exploring them to meaningful manipulation. It also covers the development of communication and language comprehension, spatial relationship and manual dexterity, imitative behavior and social interaction etc.
Time frame: 6 months (± 4 weeks)
Difference in numbers / proportions of infants with developmental delay
Difference in numbers / proportions of infants with developmental delay between the Docosa-hexaenoic acid (DHA) and placebo group at 6 and 12 months. Developmental delay will be defined as a Development Quotient score ≤70 as assessed by Development Assessment Scale for Indian Infants (DASII).
Time frame: 6 months (± 4 weeks) and 12 (± 4 weeks) months
Mean difference in infant weight (in grams) at birth
Mean difference in infant weight score between the Docosahexaenoic acid (DHA) and placebo group at birth. Birth weight is measured to the nearest 10 g by using a digital pediatric scale. Low birth weight is defined as recorded birth weight less than 2500 g.
Time frame: At delivery
Mean difference in infant (in centimeters) at birth
Mean difference in infant length between the Docosahexaenoic acid (DHA) and placebo group at birth. Birth length is the height of infant from maximum convexity of head to heel of the foot of the baby just after birth. It is measured using a portable infantometer with a fixed headpiece according to standard procedures. The Body length at birth is recorded in centimetres (cm) to 1 decimal place.
Time frame: At delivery
Mean difference in infant head circumference (in centimeters) at birth
Mean difference in infant head circumference between the Docosahexaenoic acid (DHA) and placebo group at birth. Birth length is the measurement of a child's head around its largest area - the distance from above the eyebrows and ears and around the back of the head. It is measured using non-stretchable measuring tape. It should be written in cm to 1 decimal place.
Time frame: At delivery
Mean difference in infant APGAR (Appearance, Pulse, Grimace, Activity, Respiration) score at birth.
Mean difference in APGAR (Appearance, Pulse, Grimace, Activity, Respiration) score between the Docosahexaenoic acid (DHA) and placebo group at birth. The APGAR score is a way to quickly measure and simply the health of an infant immediately after birth by adding the scores of the five criteria- Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability/ response), Activity (muscle tone) and Respiration to come up with a single number. This test is done at 1, 5 minutes. A low score on the 1-minute test may show that the neonate requires medical attention but is not necessarily an indication that there will be long-term problem.
Time frame: At delivery
Mean change in infant weight (in grams) at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group
Mean change in infant weight at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group. Birth weight is measured to the nearest 10 g by using a digital pediatric scale. Low birth weight is defined as recorded birth weight less than 2500 g.
Time frame: At delivery, 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks)
Mean change in infant length (in centimeters) at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group
Mean change in infant length Docosahexaenoic acid (DHA) and placebo group at birth, 1 month, 6 months and 12 months between the DHA and placebo group. Birth length is the height of infant from maximum convexity of head to heel of the foot of the baby just after birth. It is measured using a portable infantometer with a fixed headpiece according to standard procedures. The Body length at birth is recorded in centimetres (cm) to 1 decimal place.
Time frame: At delivery, 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks)
Mean change in infant head circumference (in centimeters) at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group
Mean change in infant size head circumference Docosahexaenoic acid (DHA) and placebo group at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group. Mean difference in infant head circumference between the Docosahexaenoic acid (DHA) and placebo group at birth. Birth length is the measurement of a child's head around its largest area - the distance from above the eyebrows and ears and around the back of the head. It is measured using non-stretchable measuring tape. It should be written in cm to 1 decimal place.
Time frame: At delivery, 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks)
Mean difference in proportions of still births between Docosahexaenoic acid (DHA) and placebo groups.
Mean difference in proportions of still births between Docosahexaenoic acid (DHA) and placebo groups. Stillbirths are defined as fetuses delivered at 20 weeks of gestation or later with no signs of life and recorded as occurring before or during the onset of labor.
Time frame: At delivery
Mean difference in proportions of preterm babies between Docosahexaenoic acid (DHA) and placebo groups.
Mean difference in proportions of preterm babies between Docosahexaenoic acid (DHA) and placebo groups. Preterm delivery is defined as delivery after 20 weeks and before 37 weeks of completed gestation. Foetal losses during pregnancy - including miscarriages/abortions and still-births are recorded by study personnel on site or details are brought by field workers (in case mother went to any other hospital).
Time frame: At delivery
Mean difference in proportions of low birth weight babies between Docosahexaenoic acid (DHA) and placebo groups.
Mean difference in proportions of low birth weight babies between Docosahexaenoic acid (DHA) and placebo groups. Low birth weight is defined as recorded birth weight less than 2500 g.
Time frame: At delivery
Difference in infant morbidity patterns between Docosahexaenoic acid (DHA) and placebo groups
Difference in infant morbidity patterns (types of illness, frequency and duration of specific conditions) between DHA and placebo group. Information collected on infant morbidity include questions reporting of illnesses - cough, nasal congestion, difficulty in breathing, cyanosis, convulsions, fever, vomiting, rash, ear discharge, excessive crying, and diarrhoea from birth till the age of 12 months
Time frame: 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks)